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 |
|---|---|---|---|
| Jul 14, 2008 | K081108 | MONOPOLY PEDICLE SCREW SYSTEM Signus Medical, LLC | NKB |
| Jul 2, 2008 | K072678 | LAGUNA SIZE 8 PEDICLE SCREW Allez Spine, LLC | NKB |
| Jun 17, 2008 | K081414 | MODIFICATION TO CORAL SPINAL SYSTEM Theken Spine, LLC | NKB |
| Jun 16, 2008 | K062254 | AXIS FIXATION SYSTEM Medtronic Sofamor Danek, Inc. | NKB |
| May 30, 2008 | K081252 | EXPEDIUM 4.5MM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| May 28, 2008 | K081195 | REVERE UNIPLANAR SCREWS Globus Medical, Inc. | NKB |
| May 15, 2008 | K073562 | MODIFICATION TO VIPER SPINE SYSTEM Depuy Spine, Inc. | NKB |
| May 8, 2008 | K080313 | MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Apr 30, 2008 | K080928 | XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS Stryker Spine | NKB |
| Apr 4, 2008 | K073364 | EXPEDIUM 4.5MM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Mar 20, 2008 | K080518 | PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM Pioneer Surgical Technology | NKB |
| Mar 20, 2008 | K080504 | PIONEER LOWTOP SPINAL ROD SYSTEM Pioneer Surgical Technology | NKB |
| Mar 20, 2008 | K072116 | SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM Neurospine Innovations and Solutions | NKB |
| Mar 10, 2008 | K080258 | MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM Endius, Inc. | NKB |
| Feb 15, 2008 | K073245 | EXTENDED VERTIFLEX SPINAL SCREW SYSTEM Vertiflex, Inc. | NKB |
| Feb 11, 2008 | K073510 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM Endius, Inc. | NKB |
| Jan 30, 2008 | K073267 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM Endius, Inc. | NKB |
| Jan 29, 2008 | K073430 | VALEO PEDICLE SCREW SPINAL SYSTEM Amedica Corp. | NKB |
| Jan 4, 2008 | K073480 | LIFE SPINE CROSS CONNECTOR Life Spine | NKB |
| Jan 3, 2008 | K073517 | H-LINK INTEGRATED ROD Globus Medical, Inc. | NKB |
| Dec 20, 2007 | K072605 | MALIBU SPINAL SYSTEM Seaspine, Inc. | NKB |
| Dec 13, 2007 | K073172 | BEACON STABILIZATION SYSTEM Globus Medical, Inc. | NKB |
| Dec 7, 2007 | K072840 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM Endius, Inc. | NKB |
| Dec 6, 2007 | K073151 | MANTIS SPINAL SYSTEM Stryker Corp. | NKB |
| Dec 6, 2007 | K073126 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Nov 28, 2007 | K072672 | SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES Abbott Spine, Inc. | NKB |
| Nov 19, 2007 | K072022 | VALEO PEDICLE SCREW SPINAL SYSTEM Amedica Corp. | NKB |
| Nov 16, 2007 | K071921 | INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) Innovasis, Inc. | NKB |
| Oct 19, 2007 | K072426 | ATLAS SPINE PEDICLE SCREW SYSTEM Atlas Spine, LLC | NKB |
| Oct 12, 2007 | K071914 | MERCURY SPINAL SYSTEM Spinal Elements, Inc. | NKB |
| Sep 28, 2007 | K072429 | MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Sep 20, 2007 | K071945 | S4 SPINAL SYSTEM Aesculap Implant Systems | NKB |
| Sep 18, 2007 | K072317 | MODIFICATION TO:TSRH SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | NKB |
| Sep 18, 2007 | K070387 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Sep 6, 2007 | K070282 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM Endius, Inc. | NKB |
| Sep 5, 2007 | K072183 | ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600 Zimmer Spine, Inc. | NKB |
| Aug 27, 2007 | K071373 | STRYKER SPINE XIA III SPINAL SYSTEM Stryker Spine | NKB |
| Aug 22, 2007 | K070962 | CORAL PEDICLE SCREW SYSTEM Theken Spine, LLC | NKB |
| Aug 20, 2007 | K071380 | MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM Alphatec Spine, Inc. | NKB |
| Aug 1, 2007 | K071860 | MODIFICATION TO: VIPER SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Jul 25, 2007 | K071174 | PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS Abbott Spine, Inc. | NKB |
| Jul 13, 2007 | K070631 | DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM Stryker Spine | NKB |
| Jul 10, 2007 | K063772 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Jul 3, 2007 | K070973 | QUANTUM SPINAL SYSTEM Pioneer Surgical Technology | NKB |
| Jun 29, 2007 | K071495 | EXPEDIUM 4.5MM SPINE SYSTEM Depuy Spine, A Johnson & Johnson Company | NKB |
| Jun 28, 2007 | K063670 | MODIFICATIONS TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Jun 22, 2007 | K070995 | ARX-LINK CROSS CONNECTOR Life Spine | NKB |
| Jun 13, 2007 | K071376 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM Vertebron, Inc. | NKB |
| Jun 11, 2007 | K070460 | ALLEZ SPINE CROSS CONNECTORS Allez Spine, LLC | NKB |
| Jun 11, 2007 | K070281 | ISSYS LP SPINAL FIXATION SYSTEM Custom Spine, Inc. | NKB |
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