Panels › Orthopedic › Product code NKB · Class 2
Thoracolumbosacral Pedicle Screw System
Regulation 888.3070
33510(k)s in 12 months (914 all time)
4recalls in 12 months (182 all time)
177recalls that name a 510(k)
Top companies in NKB
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 98 | 2 |
| Depuy Spine, Inc. | 30 | 10 |
| Nuvasive, Inc. | 9 | 31 |
| Spinal Elements, Inc. | 11 | 22 |
| Stryker Spine | 22 | 5 |
| Alphatec Spine, Inc. | 20 | 5 |
| Zimmer Biomet, Inc. | 0 | 25 |
| Globus Medical, Inc. | 24 | 0 |
| Life Spine | 22 | 0 |
| K2m | 20 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 2004 | K042790 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Sep 8, 2004 | K042167 | MODIFICATION TO: CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Sep 8, 2004 | K041801 | EXPEDIUM MIS SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Jul 23, 2004 | K041167 | PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM Pioneer Surgical Technology | NKB |
| Mar 31, 2004 | K033901 | MERLIN SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Mar 9, 2004 | K032560 | ARROWHEAD SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Jan 13, 2004 | K033312 | EBI TOP LOADING MAS SPINAL FIXATION SYSTEM Ebi, L.P. | NKB |
| Sep 12, 2003 | K032033 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Aug 8, 2003 | K030369 | OPUS SPINAL SYSTEM Howmedica Osteonics Corp. | NKB |
| 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 17, 2003 | K030087 | SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM Spinal Concepts, Inc. | NKB |
| Mar 28, 2003 | K030625 | SPINAL CONCEPTS INC. PATHFINDER Spinal Concepts, Inc. | NKB |
| Feb 25, 2003 | K030285 | MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | NKB |
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