Panels › Orthopedic › Product code MAX · Class 2
Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation 888.3080
20510(k)s in 12 months (897 all time)
5recalls in 12 months (116 all time)
105recalls that name a 510(k)
Top companies in MAX
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 55 | 12 |
| Globus Medical, Inc. | 20 | 22 |
| Nu Vasive, Incorporated | 34 | 0 |
| Life Spine | 33 | 0 |
| Alphatec Spine | 22 | 3 |
| Spineology, Inc. | 22 | 0 |
| SeaSpine Orthopedics Corporation | 20 | 1 |
| Spinal Elements | 17 | 2 |
| Stryker | 17 | 0 |
| K2m | 13 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2012 | Alphatec Spine, Inc. SOLUS Anterior Lumbar Interbody Fusion Spinal
Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402.
The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated f Terminated |
MAX | K102402 |
| Feb 15, 2012 | Orthofix, Inc. Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Cas Terminated |
MAX | K103111 |
| Nov 4, 2011 | Synthes USA (HQ), Inc. Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system.
Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in pa Terminated |
MAX | K100089 |
| Nov 12, 2009 | Alphatec Spine, Inc. Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124.
Spinal fixation system consistin Terminated |
MAX | K080699 |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF 7960020; 25MM, REF 7960025, 30MM, REF 7960030; and 35MM, REF 7960035; QTY: 1 EA, NON-STERILE, Rx o Terminated |
MAX | K080083 |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System Coverplate, size: Small, Part Number: REF 7961330; medium, REF 7962330; large, REF 7963330; STERILE R.
The INTREPID Spinal System is indicated for use with autogenou Terminated |
MAX | K080083 |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER L 42X30, 12 DEG, Size: 10MM, Part Number: REF 7963210; 12MM, REF 7963212, 14MM, REF 7963214; 16MM, REF 7963216; 18MM, REF 7963218; 20MM, REF 7963220; USA, Rx on Terminated |
MAX | K080083 |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10MM: Part Number: REF 7963810; 12MM, REF 7963812; 14MM, REF 7963814; 16MM, REF 7963816; 18MM, REF 7963818; 20MM, REF 7963820; USA, Rx onl Terminated |
MAX | K080083 |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10MM, Part Number: REF 7962210; 12MM, REF 7962212; 14MM, REF 7962214; 16MM, REF 7962216; 18MM, REF 7962218; 20MM, REF 7962220; USA, Rx on Terminated |
MAX | K080083 |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number: REF 7962810; 12MM, REF 7962812; 14MM, REF 7962814; 16MM, REF 7962816; 18MM, REF 7962818; 20MM, REF 7962820; USA, Rx only Terminated |
MAX | K080083 |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10MM, Part Number: REF 7961210; 12MM, REF 7961212; 14MM, REF 7961214; 16MM, REF 7961216; 18MM, REF 7961218; 20MM, REF 7961220; Rx only, ST Terminated |
MAX | K080083 |
| Jul 24, 2009 | Medtronic Sofamor Danek USA Inc Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STE Terminated |
MAX | K080083 |
| Jan 30, 2009 | Synthes Spine Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231.
The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contig Terminated |
MAX | K072253 |
| Oct 20, 2008 | Stryker Spine Ray TFC Device with End Caps:
Single Patient use; Sterile;
Stryker Spine
Ray Cage 7-2021 20 (catalog #) mm diameter x 21 mm long.
Ray Cages are indicated for use with autogenous bone graft in patient Terminated |
MAX | None listed |
| Jun 8, 2006 | Medtronic Sofamor Danek USA Inc 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusion) Terminated |
MAX | K051320 |
| Aug 6, 2005 | Warsaw Orthopedic, Inc. Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423. Terminated |
MAX | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.