Panels › Orthopedic › Product code HSB · Class 2
Rod, Fixation, Intramedullary And Accessories
Regulation 888.3020
20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
Top companies in HSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 295 |
| DePuy Orthopaedics, Inc. | 9 | 116 |
| Zimmer GmbH | 23 | 50 |
| Stryker | 12 | 37 |
| Howmedica Osteonics | 39 | 0 |
| OrthoPediatrics Corp. | 7 | 31 |
| Ebi, L.P. | 1 | 31 |
| Advanced Orthopaedic Solutions, Inc. | 15 | 12 |
| NuVasive Specialized Orthopedics | 18 | 9 |
| Synthes (Usa) | 23 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 10mm x 17cm x 130, Product Part Number: 1040-170 Terminated |
HSB | K021008 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 11mm x 20cm x 135, Product Part Number: 1038-200. Terminated |
HSB | K021008 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 13mm x 20cm x 130, Product Part Number: 1037-200. Terminated |
HSB | K021008 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 11mm x 20cm x 130, Product Part Number: 1036-200. Terminated |
HSB | K021008 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 11mm x 17cm x 130, Product Part Number: 1036-170. Terminated |
HSB | K021008 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 9mm x 20cm x 130, Product Part Number: 1034-200. Terminated |
HSB | K021008 |
| Mar 22, 2010 | Advanced Orthopaedic Solutions Inc AOS Trochanteric Nail, 9mm x 17cm x 130, Product Part Number: 1034-170. Terminated |
HSB | K021008 |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, right; 012 x 300 mm; Catalog number: 18191230S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
Int Terminated |
HSB | K051590 |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog number: 18191130S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
In Terminated |
HSB | K051590 |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, right; 010 x 300 mm; Catalog number: 18191030S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
In Terminated |
HSB | K051590 |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, left; 012 x 300 mm; Catalog number: 18181230S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
Int Terminated |
HSB | K051590 |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, left; 011 x 300 mm; Catalog Number: 18181130S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
Inte Terminated |
HSB | K051590 |
| Feb 24, 2010 | Stryker Howmedica Osteonics Corp. Stryker T2 Ankle Arthrodesis Nail, left; 010 x 300 mm; Catalog number 18181030S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.
Int Terminated |
HSB | K051590 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Connecting Knob, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-000-11.
The device is used to drill into the proximal tibia or distal femur for placement of screws that stabi Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Tibial Module, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-04.
The device is used to drill into the proximal tibia or distal femur for placement of screws that stabili Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Recon Module, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-08.
The device is used to drill into the proximal tibia or distal femur for placemen Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Interlock Module, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-03.
The device is used to drill into the proximal tibia or distal femur for plac Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral interlock Module, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-53.
The device is used to drill into the proximal tibia or distal femur for place Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Recon Module, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-08.
The device is used to drill into the proximal tibia or distal femur for place Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Interlock Module, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-03.
The device is used to drill into the proximal tibia or distal femur for p Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, 0.512" wide, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-10.
The device is used to drill into the proximal tibia or di Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-00.
The device is used to drill into the proximal tibia or distal femur fo Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Tibial Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-03.
The device is used to drill into the proximal tibia or distal femur for placement Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-00.
The device is used to drill into the proximal tibia or distal femur for placement Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, 0.512" wide, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-10.
The device is used to drill into the proximal tibia or Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-05.
The device is used to drill into the proximal tibia or distal femur for Terminated |
HSB | K082770 K083497 +1 |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-00.
The device is used to drill into the proximal tibia or distal femur Terminated |
HSB | K082770 K083497 +1 |
| Nov 13, 2009 | Orthofix, Inc Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Internal Limb Lengthener, Locking Screws, Instrumentation and an external hand-held Terminated |
HSB | None listed |
| 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 |
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