Panels › Orthopedic › Product code NQP · Class 2
Posterior Metal/Polymer Spinal System, Fusion
Regulation 888.3070
0510(k)s in 12 months (22 all time)
0recalls in 12 months (50 all time)
50recalls that name a 510(k)
Top companies in NQP
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 4 | 34 |
| Zimmer Inc. | 0 | 7 |
| Zimmer Spine, Inc. | 7 | 0 |
| Paradigm Spine | 5 | 0 |
| Synthes USA (HQ), Inc. | 0 | 5 |
| Synthes Spine | 0 | 4 |
| N Spine, Inc. | 2 | 0 |
| Biospine Co., Ltd. | 1 | 0 |
| Centerpulse Spine-Tech, Inc. | 1 | 0 |
| Globus Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2021 | K203678 | CD HORIZON Spinal System Medtronic Sofamor Danek USA, Inc. | NQP |
| Oct 3, 2019 | K191066 | CD Horizon Astute Spinal System Medtronic Sofamor Danek USA, Inc. | NQP |
| Jan 11, 2019 | K182928 | CD Horizon Spinal System Medtronic Sofamor Danek USA, Inc. | NQP |
| Jan 16, 2014 | K133164 | DYNESYS TOP-LOADING SPINAL SYSTEM Zimmer Spine, Inc. | NQP |
| Aug 18, 2010 | K101704 | ZIMMER DTO PIN PRESS INSTRUMENT Zimmer Spine, Inc. | NQP |
| Jul 2, 2010 | K101083 | DSS STABILIZATION SYSTEM Paradigm Spine, LLC | NQP |
| Oct 1, 2009 | K092234 | DYNESYS TOP-LOADING SPINAL SYSTEM Zimmer Spine, Inc. | NQP |
| Aug 3, 2009 | K091944 | MODIFICATION TO: DSS STABILIZATION SYSTEM Paradigm Spine, LLC | NQP |
| Feb 20, 2009 | K073439 | TRANSITION STABILIZATION SYSTEM Globus Medical, Inc. | NQP |
| Nov 28, 2008 | K080241 | DDS STABILIZATION SYSTEM Paradigm Spine, LLC | NQP |
| May 2, 2008 | K080963 | DSS STABILIZATION SYSTEM Paradigm Spine | NQP |
| Apr 17, 2008 | K071261 | ISOBAR SEMI-RIGID DUAL DAMPENER Scient'X | NQP |
| Mar 25, 2008 | K072321 | BIOFLEX Biospine Co., Ltd. | NQP |
| Feb 8, 2008 | K073347 | DYNESYS TOP-LOADING SPINAL SYSTEM Zimmer Spine, Inc. | NQP |
| Jan 24, 2008 | K072969 | DSS Paradigm Spine, LLC | NQP |
| Oct 19, 2007 | K072685 | NGARDE SYSTEM N Spine, Inc. | NQP |
| Oct 5, 2007 | K071879 | ZIMMER DTO IMPLANT Zimmer Spine, Inc. | NQP |
| Dec 13, 2006 | K061774 | NFIX II PEDICLE SCREW SYSTEM N Spine, Inc. | NQP |
| Jul 18, 2006 | K061304 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NQP |
| Apr 6, 2006 | K060638 | DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS Zimmer Spine, Inc. | NQP |
| Mar 11, 2005 | K043565 | MODIFICATION TO DYNESYS SPINAL SYSTEM Zimmer Spine, Inc. | NQP |
| Mar 5, 2004 | K031511 | DYNESYS SPINAL SYSTEM Centerpulse Spine-Tech, Inc. | NQP |
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