Company ยท US
SpineFrontier, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2020. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
33recalls (0 in 12 months)
23recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 8 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 |
| MNI | Orthosis, Spinal Pedicle Fixation | 6 |
| FSM | Tray, Surgical, Instrument | 4 |
| HXX | Screwdriver | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 |
| HTE | Elevator | 3 |
| LXH | Orthopedic Manual Surgical Instrument | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 |
| FTY | Tape, Measuring, Rulers And Calipers | 1 |
| FZX | Guide, Surgical, Instrument | 1 |
| FZY | Hammer, Surgical | 1 |
| HWA | Impactor | 1 |
| HXB | Probe | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 |
| OUR | Sacroiliac Joint Fixation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 19, 2020 | K193106 | SpineFrontier Lumbar Interbody Fusion Device System Spinefrontier, Inc. | MAX |
| May 8, 2018 | K172484 | A-CIFT SoloFuse Spinefrontier, Inc. | OVE |
| Jul 17, 2015 | K151198 | A-CIFT SoloFuse Spinefrontier, Inc. | OVE |
| May 13, 2015 | K142504 | SpineFrontier Lumbar Interbody Fusion Device System Spinefrontier, Inc. | MAX |
| Apr 24, 2015 | K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System Spinefrontier, Inc. | OUR |
| Feb 12, 2015 | K143377 | PedFuse Pedicle Screw System Spinefrontier, Inc. | MNH |
| Nov 25, 2014 | K141333 | ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE Spinefrontier, Inc. | ODP |
| Oct 20, 2014 | K142026 | SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE Spinefrontier, Inc. | ODP |
| Sep 8, 2014 | K141337 | ARENA-C Spinefrontier, Inc. | ODP |
| May 14, 2014 | K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Spinefrontier, Inc. | MNH |
| Jan 3, 2014 | K131880 | SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM Spinefrontier, Inc. | OVE |
| Nov 26, 2013 | K132740 | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM Spinefrontier, Inc. | NQW |
| Feb 15, 2013 | K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Spinefrontier, Inc. | MNH |
| Jul 3, 2012 | K121060 | SPINE FRONTIER INDUS ACP SYSTEM Spinefrontier, Inc. | KWQ |
| Feb 16, 2012 | K113518 | ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM Spinefrontier, Inc. | ODP |
| Sep 28, 2011 | K111553 | SPINEFRONTIER LUMBAR IBF SYSTEM Spinefrontier, Inc. | MAX |
| Sep 1, 2010 | K102020 | VEGA SPAN SPINOUS PROCESS PLATE SYSTEM Spinefrontier, Inc. | KWP |
| Jun 30, 2010 | K092815 | S-LIF INTERVERTEBRAL BODY FUSION DEVICE Spinefrontier, Inc. | MAX |
| Mar 26, 2010 | K093776 | INDUS ANTERIOR CERVICAL PLATE SYSTEM Spinefrontier, Inc. | KWQ |
| Nov 19, 2009 | K092420 | KRD1 PEDICLE SCREW SYSTEM Spinefrontier, Inc. | MNI |
| Sep 14, 2009 | K091638 | DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 Spinefrontier, Inc. | MAX |
| Feb 20, 2008 | K073232 | INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX Spinefrontier, Inc. | KWQ |
| Jan 16, 2008 | K071420 | CHAMELEON FIXATION SYSTEM Spinefrontier, Inc. | MRW |
| Nov 1, 2007 | K072289 | SPINEFRONTIER DORADO VBR Spinefrontier, Inc. | MAX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2019 | SpineFrontier, Inc. A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106) Terminated |
OVE | K172484 |
| Apr 21, 2015 | SpineFrontier, Inc. SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Terminated |
FTY | K123164 |
| Jan 14, 2015 | SpineFrontier, Inc. lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 Terminated |
LXH | None listed |
| May 7, 2014 | SpineFrontier, Inc. SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, I Terminated |
MAX | K092815 |
| Jan 16, 2014 | SpineFrontier, Inc. Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14
The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stain Terminated |
HTE | None listed |
| Jan 16, 2014 | SpineFrontier, Inc. Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16
The trial heads are smooth plates that mimic the footprint of the implant, manufactured f Terminated |
HTE | None listed |
| Jan 16, 2014 | SpineFrontier, Inc. Arena-L Trial Handle; Part: 11-81002
The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012 Terminated |
HTE | None listed |
| Jan 3, 2014 | SpineFrontier, Inc. PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. Terminated |
HXB | K123164 |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | K121060 |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | K121060 |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | K121060 |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | K121060 |
| Dec 20, 2013 | SpineFrontier, Inc. PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113
The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw c Terminated |
MNI | K123164 |
| Dec 20, 2013 | SpineFrontier, Inc. PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111
The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw Terminated |
MNI | K123164 |
| Dec 20, 2013 | SpineFrontier, Inc. PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110
The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw c Terminated |
MNI | K123164 |
| Dec 19, 2013 | SpineFrontier, Inc. PedFuse Reset Screw; Model: 01-80115-55
The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the Terminated |
MNI | K123164 |
| Nov 14, 2013 | SpineFrontier, Inc. S-LIFT Extension Shims
Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varie Terminated |
LXH | K092815 |
| Aug 13, 2013 | SpineFrontier, Inc. Invue Solid Driver, Tipped, AO. Part Number: 11-70083.
Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral. Terminated |
HXX | K121060 |
| Aug 13, 2013 | SpineFrontier, Inc. Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift L Terminated |
FSM | None listed |
| Aug 8, 2013 | SpineFrontier, Inc. Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060.
The Invue Driver is an instr Terminated |
HXX | None listed |
| Aug 8, 2013 | SpineFrontier, Inc. Indus Invue Screw Caddy, Model: SI70097
The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates t Terminated |
FSM | K121060 |
| Aug 8, 2013 | SpineFrontier, Inc. T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A
T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal Terminated |
MDM | K092815 |
| Aug 8, 2013 | SpineFrontier, Inc. Rev E PedFuse Return Screw Inserter, Part Number: 11-80030
Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds Terminated |
HXX | K092420 |
| Aug 2, 2013 | SpineFrontier, Inc. Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A
FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protect Terminated |
FZX | K071420 |
| Aug 1, 2013 | SpineFrontier, Inc. S-LIFT Slap Hammer, Part Number: 11-50204, Revision A
The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to Terminated |
FZY | None listed |
| Aug 1, 2013 | SpineFrontier, Inc. Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B
The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw Terminated |
FSM | None listed |
| Jul 16, 2013 | SpineFrontier, Inc. KRD1 PedFuse Rods, Model: IM80100-13 Rev B
Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and th Terminated |
MNI | K092420 |
| Jul 5, 2013 | SpineFrontier, Inc. InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly
Product Usage:
Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination Terminated |
HXX | None listed |
| Jul 5, 2013 | SpineFrontier, Inc. BASE, S-LIFT Instrument Case
Product Usage:
System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants Terminated |
FSM | K092815 |
| Jul 5, 2013 | SpineFrontier, Inc. S-LIFT Inserter Outer Sleeve
Product Usage:
The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Terminated |
LXH | K092815 |
| Jun 5, 2013 | SpineFrontier, Inc. Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion device Terminated |
HWA | None listed |
| Nov 21, 2012 | SpineFrontier, Inc. Spine Frontier Inspan compressors
Part Number: 11-60004.
Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant. Terminated |
KWP | K093438 |
| Nov 21, 2012 | SpineFrontier, Inc. S-Lift Implant Guides (also known as S-LIF)
Compressor Part Number: 11-50223
Product Usage:
Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, witho Terminated |
MAX | K092815 |