Company ยท US
Ebi, L.P.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2020. Name variants (Inc, Corp, punctuation) are merged.
103510(k) clearances (0 in 12 months)
61recalls (0 in 12 months)
49recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 38 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 32 |
| NKB | Thoracolumbosacral Pedicle Screw System | 13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 9 |
| MQP | Spinal Vertebral Body Replacement Device | 8 |
| HRS | Plate, Fixation, Bone | 6 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 |
| DZE | Implant, Endosseous, Root-Form | 4 |
| HXX | Screwdriver | 4 |
| LOF | Stimulator, Bone Growth, Non-Invasive | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 |
| HXI | Passer, Wire, Orthopedic | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 |
| MQV | Filler, Bone Void, Calcium Compound | 3 |
| BSO | Catheter, Conduction, Anesthetic | 2 |
| HAW | Neurological Stereotaxic Instrument | 2 |
| HRX | Arthroscope | 2 |
| HWC | Screw, Fixation, Bone | 2 |
| NDF | Plate, Fixation, Bone, Non-Spinal, Metallic | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 2020 | K190837 | Internal Hex Implant System Ebi, Inc., KR | DZE |
| Aug 31, 2017 | K170031 | Internal Octa Implant System Ebi, Inc., KR | DZE |
| Mar 27, 2015 | K142426 | EBI External Implant System Ebi, Inc., KR | DZE |
| Dec 15, 2014 | K140734 | NEXTGEN ALTIUS OCT SYSTEM Ebi, LLC | KWP |
| Apr 24, 2014 | K140123 | POLARIS SPINAL SYSTEM -TRANSLATION SCREW Ebi, LLC | NKB |
| Apr 26, 2012 | K113796 | SOLITAIRE-C CERVICAL SPACER SYSTEM Ebi, LLC | OVE |
| Aug 3, 2011 | K111376 | CONSTRUX EXTERNAL FIXATION DEVICE Ebi, LLC | KTT |
| Jun 23, 2010 | K100438 | POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM Ebi, L.P. | NKB |
| May 17, 2010 | K100220 | POLARIS SPINAL SYSTEM Ebi, L.P. | NKB |
| Apr 16, 2010 | K093880 | PEANUT GROWTH CONTROL PLATING SYSTEM Ebi, L.P. | HRS |
| Feb 4, 2010 | K092574 | ESL SPINAL SYSTEM Ebi, L.P. | MAX |
| Dec 1, 2009 | K093057 | BIOMET VISION FOOTRING SYSTEM Ebi, L.P. | KTT |
| Oct 15, 2009 | K092336 | C-THRU SPINAL SYSTEM Ebi, L.P. | MQP |
| Aug 7, 2009 | K091381 | IBEX SPINAL SYSTEM Ebi, L.P. | MAX |
| Jul 30, 2009 | K090203 | 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS Ebi, L.P. | NKB |
| Jul 1, 2009 | K090523 | POLARIS SPINAL SYSTEM Ebi, L.P. | NKB |
| Jan 14, 2009 | K082406 | EXPANDABLE PEEK-OPTIMA IMPLANT Ebi, L.P. | MAX |
| Nov 13, 2008 | K082187 | BIOMET ANTERIOR LUMBAR PLATE Ebi, L.P. | KWQ |
| Feb 28, 2008 | K073116 | EBI INTERNAL IMPLANT SYSTEM Ebi, Inc. | DZE |
| Apr 18, 2007 | K063346 | PRO OSTEON 500R Ebi, L.P. | MQV |
| Oct 19, 2006 | K062494 | EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM Ebi, L.P. | HRS |
| Oct 17, 2006 | K062810 | SOLITAIRE ANTERIOR SPINAL SYSTEM Ebi, L.P. | MQP |
| Oct 6, 2006 | K062685 | EBI ARAY SPINAL SYSTEM Ebi, L.P. | NKB |
| Aug 11, 2006 | K061978 | EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM Ebi, L.P. | MNI |
| Jul 25, 2006 | K061441 | EBI 5.5 HELICAL FLANGE SPINAL SYSTEM Ebi, L.P. | MNH |
| Jun 23, 2006 | K061563 | EBI ARRAY SPINAL SYSTEM Ebi, L.P. | NKB |
| Jun 8, 2006 | K061016 | EBI ESL PEEK-OPTIMA SPINE SYSTEM Ebi, L.P. | MQP |
| May 24, 2006 | K061098 | EBI OPTILOCK PERIARTICULAR PLATING SYSTEM Ebi, L.P. | HRS |
| Mar 13, 2006 | K060148 | EBI VERTEBROPLASTY SYSTEMS Ebi, L.P. | NDN |
| Mar 6, 2006 | K060379 | EBI ANTERIOR CERVICAL PLATE SYSTEM Ebi, L.P. | KWQ |
| Sep 21, 2005 | K052239 | EBI DYNAFIX VISION FOOTPLATE SYSTEM Ebi, L.P. | KTT |
| Jul 19, 2005 | K051724 | ACUMEN IMAGE GUIDED SURGICAL SYSTEM Ebi, L.P. | HAW |
| Feb 16, 2005 | K050118 | EBI TROCHANTERIC NAIL SYSTEM Ebi, L.P. | HSB |
| Dec 13, 2004 | K042772 | EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE Ebi, L.P. | NKB |
| Oct 27, 2004 | K042268 | EBI CAS SPINE SPACER SYSTEM Ebi, L.P. | MQP |
| Sep 16, 2004 | K042237 | EBI PERIARTICULAR PLATING SYSTEM Ebi, L.P. | HRS |
| Aug 16, 2004 | K033918 | EBI LACTOSORB GRAFT CONTAINMENT SYSTEM Ebi, L.P. | HRS |
| Jul 6, 2004 | K040935 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Jun 25, 2004 | K040908 | EBI DISTAL RADIUS PLATING SYSTEM Ebi, L.P. | HRS |
| Apr 29, 2004 | K040833 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. | KTT |
| Apr 16, 2004 | K040482 | EBI ESL SPINE SPACER SYSTEM Ebi, L.P. | MQP |
| Jan 13, 2004 | K033312 | EBI TOP LOADING MAS SPINAL FIXATION SYSTEM Ebi, L.P. | NKB |
| Dec 3, 2003 | K033635 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. | KTT |
| Oct 15, 2003 | K031732 | EBI ACUMEN SURGICAL NAVIGATION SYSTEM Ebi, L.P. | HAW |
| Sep 4, 2003 | K031919 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Aug 29, 2003 | K032390 | MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM Ebi, L.P. | BSO |
| Aug 6, 2003 | K031354 | EBI OMEGA21 SPINAL FIXATION SYSTEM Ebi, L.P. | MNI |
| Jul 22, 2003 | K031424 | EBI SPINELINK SPINAL FIXATION SYSTEM Ebi, L.P. | NKB |
| Jul 22, 2003 | K031355 | EBI SPINELINK - II SPINAL FIXATION SYSTEM Ebi, L.P. | NKB |
| Jul 10, 2003 | K031093 | EBI XFIX OPTIROM KNEE FIXATOR Ebi, L.P. | KTT |
Newest 50 of 103.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2024 | EBI, LLC 48" Lead Wires, Replacement
Part Number: 1067724-4 Open, Classified |
LOF | None listed |
| Apr 23, 2024 | EBI, LLC 20" Lead Wires, Replacement
Part Number: 1067724-2 Open, Classified |
LOF | None listed |
| Apr 23, 2024 | EBI, LLC Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated
for the treatment of an established nonunion acquired secondary to trauma,
excluding vertebrae and all flat bones.
Part Number: 106 Open, Classified |
LOF | None listed |
| Apr 23, 2024 | EBI, LLC Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated
for the treatment of an established nonunion acquired secondary to trauma,
excluding vertebrae and all flat bones,
Part Number: Open, Classified |
LOF | None listed |
| Jan 5, 2015 | Ebi, Llc Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the de Terminated |
NKB | K123549 |
| Dec 24, 2014 | Ebi, Llc Solitaire-C Cervical Spacer System
a) 14-531593 Drill/Awl Sleeve
b) 14-531594 Spring-Loaded Drill/Awl Sleeve
Intended to stabilize cervical spinal segment to promote fusion in order to restrict moti Terminated |
OVE | K113796 |
| Jun 17, 2014 | Ebi, Llc Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System. Terminated |
HXX | None listed |
| Nov 27, 2013 | Ebi, Llc Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054
The Polaris Spinal Systems is a non-cervical spinal fixation device intended for im Terminated |
HXX | None listed |
| Nov 19, 2013 | Ebi, Llc BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile.
Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation Terminated |
HWC | K123549 |
| Sep 27, 2013 | Ebi, Llc Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device. Terminated |
MAX | K093629 |
| Sep 17, 2013 | Ebi, Llc Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device.
1)Screw Tower - REF 14-501660
2) Rod Reduce - REF 14-501661
3) Counter Terminated |
LXH | None listed |
| Mar 15, 2013 | Ebi, Llc Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device. Terminated |
HXX | None listed |
| Dec 17, 2012 | Ebi, Llc Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 Terminated |
HXX | None listed |
| Oct 22, 2010 | Ebi, Llc ARRAY and POLARIS Spinal System Medium Cross Connector
Non Sterile
Biomet Spine, Parsippany, NJ. 07054 Terminated |
NKB | K062685 |
| Sep 22, 2009 | EBI, L.P. Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar;
Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fract Terminated |
KWP | K993956 |
| Sep 22, 2009 | EBI, L.P. Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System;
Made in USA
Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
MQP | K993956 |
| Sep 22, 2009 | EBI, L.P. Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System
Made in USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
MQP | K993956 |
| Sep 22, 2009 | EBI, L.P. Fixed Closed Screw (Ti);
6.0MM (D) x 40 MM (L)
Made In USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of Terminated |
MNI | K993956 |
| Sep 22, 2009 | EBI, L.P. Fixed Closed Screw (Ti);
5.0MM (D) x 25MM (L);
Made in USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of Terminated |
MNH | K993956 |
| Sep 22, 2009 | EBI, L.P. Fixed Open Screw (TI);
7.0MM (D) x 30MM (L);
Made In USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fr Terminated |
MNH | K993956 |
| Sep 22, 2009 | EBI, L.P. Fixed Closed Screw, 6.5mm (D) x 40mm (L),
Made in USA; Biomet Spine, Parsippany, NJ
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures t Terminated |
MNH | K993956 |
| Sep 22, 2009 | EBI, L.P. Pediatric Femoral Nail 5.5MM (d) x 36 CM (L)
Rx only, Sterile;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment a Terminated |
HSB | K993956 |
| Sep 22, 2009 | EBI, L.P. Pediatric Femoral Nail 5.5MM (d) x 32 CM (L)
Rx only, Sterile;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054The screw devices are an internal fixation device intended to aid in the alignment an Terminated |
HSB | K993956 |
| Sep 22, 2009 | EBI, L.P. Pediatric Femoral Nail 5.5MM (d) x 30 CM (L)
Rx only, Sterile;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment a Terminated |
HSB | K993956 |
| Sep 22, 2009 | EBI, L.P. Pediatric Femoral Nail 5.5MM (d) x 28 CM (L)
Rx only, Sterile;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment a Terminated |
HSB | K993956 |
| Sep 22, 2009 | EBI, L.P. C-Tek Maxan Anterior Cervical Plate System;
4.0MM X 20MM Fixed Screw'
Biomet Spine, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in th Terminated |
HSB | K061441 |
| Sep 22, 2009 | EBI, L.P. Cannulated Screw Ballista Percutaneous Pedicle Screw System. 6/5 x 45MM;
Biomet Spine, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | K061441 |
| Sep 22, 2009 | EBI, L.P. Bone Screw4.5MM X 95MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizati Terminated |
HSB | K042237 |
| Sep 22, 2009 | EBI, L.P. Bone Screw 4.5MM X 70MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizat Terminated |
HSB | K042237 |
| Sep 22, 2009 | EBI, L.P. Bone Screw .5MM X 60MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizati Terminated |
HSB | K042237 |
| Sep 22, 2009 | EBI, L.P. Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabil Terminated |
HSB | K042237 |
| Sep 22, 2009 | EBI, L.P. Bone Screw 4.5MM X 36MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizat Terminated |
HSB | K042237 |
| Sep 22, 2009 | EBI, L.P. Bone Screw 4.5MM X 28MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizat Terminated |
HSB | K042237 |
| Sep 22, 2009 | EBI, L.P. Bone Screw 4.5MM X 20MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizat Terminated |
HSB | K042237 |
| Sep 22, 2009 | EBI, L.P. Bone Screw 5.5MM X 70MM Bone Screw Lck-Cann, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabil Terminated |
HSB | K042237 |
| Sep 22, 2009 | EBI, L.P. Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabil Terminated |
HSB | K042237 |
| Sep 22, 2009 | EBI, L.P. Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabil Terminated |
HSB | K042237 |
| Sep 22, 2009 | EBI, L.P. TI Screw Buttress Thread 6MM (D) x 65MM (L)
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | K982953 |
| Sep 22, 2009 | EBI, L.P. TI Screw Buttress Thread 5MM (D) x 35MM (L)
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | K982953 |
| Sep 22, 2009 | EBI, L.P. TI Cannulated Screw 32MM thrd 7.3MM (d) X 120MM (L);
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended t Terminated |
HSB | K984209 |
| Sep 22, 2009 | EBI, L.P. TI Cannulated Screw 32MM thrd 7.3MM (d) X 100MM (L);
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended t Terminated |
HSB | K984209 |
| Sep 22, 2009 | EBI, L.P. TI Cannulated Screw 32MM thrd 7.3MM (d) X 95MM (L);
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to Terminated |
HSB | K984209 |
| Sep 22, 2009 | EBI, L.P. TI Cannulated Screw 20MM thrd 6.5MM (d) X 85MM (L);
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to Terminated |
HSB | K984209 |
| Sep 22, 2009 | EBI, L.P. TI Cann Partl Thd Recon Screw 6.00MM x 95MM;
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | K072161 |
| Sep 22, 2009 | EBI, L.P. TI Cann Partl Thd Recon Screw 6.00MM x 90MM;
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | K072161 |
| Sep 22, 2009 | EBI, L.P. TI Cann Partl Thd Recon Screw 6.00MM x 85MM;
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | K072161 |
| Sep 22, 2009 | EBI, L.P. TI Cann Partl Thd Recon Screw 6.00MM x 80MM;
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | K072161 |
| Sep 22, 2009 | EBI, L.P. TI Cann Partl Thd Recon Screw 6.00MM x 75MM;
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | K072161 |
| Sep 22, 2009 | EBI, L.P. TI Cann Partl Thd Recon Screw 6.00MM x 70MM;
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | K072161 |
| Sep 22, 2009 | EBI, L.P. TI Cann Partl Thd Recon Screw 6.00MM x 65MM;
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | K072161 |
Newest 50 of 61.