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 |
|---|---|---|---|
| Jan 25, 2012 | K111634 | XENON(TM) PEDICLE SCREW SYSTEM Alphatec Spine, Inc. | NKB |
| Jan 19, 2012 | K113173 | NANOVIS SPINAL SYSTEM Nanovis, LLC | NKB |
| Jan 17, 2012 | K113366 | LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM Phygen, LLC | NKB |
| Jan 10, 2012 | K113625 | DSS STABILIZATION SYSTEM Paradigm Spine, LLC | NKB |
| Jan 4, 2012 | K112643 | FOCUS MIS SYSTEM L&K BIOMED Co., Ltd., KR | NKB |
| Dec 21, 2011 | K113044 | SYNTHES MIRS Synthes Spine | NKB |
| Dec 19, 2011 | K113434 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) Lanx, Inc. | NKB |
| Dec 16, 2011 | K113270 | INSTINCT JAVA SYSTEM Zimmer Spine | NKB |
| Dec 7, 2011 | K110046 | ATHENA PEDICLE SCREW SYSTEM Royal Oak Medical Devices | NKB |
| Nov 21, 2011 | K113174 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | NKB |
| Nov 21, 2011 | K112551 | S4 SPINAL SYSTEM Aesculap Implant System, Inc. | NKB |
| Nov 18, 2011 | K111358 | SYNTHES USS Synthes Spine | NKB |
| Nov 15, 2011 | K112453 | STERISPINEPS PEDICLE SCREW Safe Orthopaedics, FR | NKB |
| Nov 2, 2011 | K112931 | LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM Phygen, LLC | NKB |
| Oct 27, 2011 | K110655 | MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM Mahe Medical GmbH, GR | NKB |
| Oct 26, 2011 | K110551 | EXPEDIUM SPINE SYSTEM Johnson & Johnson | NKB |
| Oct 21, 2011 | K112473 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | NKB |
| Oct 18, 2011 | K112759 | APCLO PEDICLE SCREW SYSTEMS Atlas Spine, Inc. | NKB |
| Sep 27, 2011 | K112555 | CD HORIZON(R) SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | NKB |
| Sep 15, 2011 | K111510 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | NKB |
| Sep 15, 2011 | K111457 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Sep 7, 2011 | K111729 | PILOT SPINAL SYSTEM Life Spine, Inc. | NKB |
| Aug 30, 2011 | K111942 | TSRH SPINAL SYSTEMS Medtronic Sofamor Danek USA, Inc. | NKB |
| Aug 26, 2011 | K111301 | INSTINCT JAVA SYSTEM Zimmer Spine | NKB |
| Aug 23, 2011 | K111502 | STREAMLINE TL SPINAL SYSTEM Pioneer Surgical Technology, Inc. | NKB |
| Aug 19, 2011 | K111957 | POLARIS SPINAL SYSTEM Biomet Spine (Ebi, LLC) | NKB |
| Aug 17, 2011 | K111479 | REVERE CROSSTOP Globus Medical, Inc. | NKB |
| Aug 17, 2011 | K111449 | REVOLVE ADDITIONAL IMPLANTS Globus Medical, Inc. | NKB |
| Aug 4, 2011 | K111478 | STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT) Stryker Corporation | NKB |
| Aug 2, 2011 | K110679 | DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM Phygen, LLC | NKB |
| Jul 26, 2011 | K110906 | APEX SPINE SYSTEM Spinecraft, LLC | NKB |
| Jul 21, 2011 | K103671 | GENESYS SPINE TILOCK SYSTEM Genesys Spine | NKB |
| Jul 13, 2011 | K110842 | ATLAS SPINE PEDICLE SCREW SYSTEM Atlas Spine, Inc. | NKB |
| Jul 12, 2011 | K111076 | SOLANAS AVALON POSTERIOR FIXATION SYSTEM Alphatec Spine, Inc. | NKB |
| Jul 6, 2011 | K111571 | VIPER SYSTEMS Johnson & Johnson | NKB |
| Jul 6, 2011 | K110280 | REVLOK FENESTRATED SCREW SYSTEM Globus Medical, Inc. | NKB |
| Jun 8, 2011 | K110070 | TSRH SPINAL SYSTEM Medtronic Sofamor Danck USA, Inc. | NKB |
| May 25, 2011 | K110588 | LEUCADIA PEDICLE SCREW SYSTEM Phygen, LLC | NKB |
| May 23, 2011 | K110676 | TSRH SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| May 12, 2011 | K110692 | STREAMLINE TL SPINAL SYSTEM Pioneer Surgical Technology, Inc. | NKB |
| May 5, 2011 | K111099 | ISSYS LP SPINAL FIXATION SYSTEM Custom Spine, Inc. | NKB |
| Apr 1, 2011 | K110216 | EXPEDIUM SYSTEM, VIPER SYSTEM Depuy Spine, Inc. | NKB |
| Mar 25, 2011 | K103237 | LANX SPINAL SYSTEM Lanx, Inc. | NKB |
| Mar 25, 2011 | K101971 | SYNTEC OS SPINAL FIXATION SYSTEM Syntec Scientific Corp., TW | NKB |
| Mar 17, 2011 | K103072 | REVERE SACRAL PLATES Globus Medical, Inc. | NKB |
| Mar 7, 2011 | K101790 | QUANTUM SPINAL SYSTEM, QUANTUM MIS Pioneer Surgical Technology | NKB |
| Mar 4, 2011 | K103292 | TRIO TRAUMA SPINAL SYSTEM Stryker Corporation | NKB |
| Mar 2, 2011 | K103748 | LAGUNA PEDICLE SCREW SYSTEM Phygen, LLC | NKB |
| Feb 17, 2011 | K103490 | EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM Johnson & Johnson | NKB |
| Feb 17, 2011 | K103383 | SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM Spartek Medical, Inc. | NKB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.