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 |
|---|---|---|---|
| May 4, 2007 | K070368 | TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM Stryker Corp. | NKB |
| Apr 12, 2007 | K070367 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM Endius, Inc. | NKB |
| Mar 29, 2007 | K070551 | MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM Pioneer Surgical Technology | NKB |
| Mar 14, 2007 | K062327 | MODIFICATION TO S4 SPINAL SYSTEM Aesculap, Inc. | NKB |
| Mar 2, 2007 | K062085 | S4 SPINAL SYSTEM Aesculap | NKB |
| Feb 9, 2007 | K062012 | S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM Aesculap, Inc. | NKB |
| Jan 18, 2007 | K063417 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Jan 17, 2007 | K063741 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Dec 11, 2006 | K063428 | XIA STAINLESS STEEL SPINAL SYSTEM Stryker Spine | NKB |
| Nov 22, 2006 | K063156 | MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Nov 22, 2006 | K062270 | RADIUS SPINAL SYSTEM Stryker Spine | NKB |
| Nov 6, 2006 | K063083 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | NKB |
| Nov 6, 2006 | K062807 | TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | NKB |
| Oct 25, 2006 | K061342 | MALIBU SPINAL SYSTEM Seaspine, Inc. | NKB |
| Oct 25, 2006 | K060615 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Oct 6, 2006 | K062685 | EBI ARAY SPINAL SYSTEM Ebi, L.P. | NKB |
| Jul 27, 2006 | K061854 | XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM Stryker Spine | NKB |
| Jul 20, 2006 | K061202 | REVERE STABILIZATION SYSTEM Globus Medical, Inc. | NKB |
| Jul 3, 2006 | K061592 | MODIFICATION TO CD HORIZON SYSTEM Medtronic Sofamor Danek, Inc. | NKB |
| Jun 23, 2006 | K061563 | EBI ARRAY SPINAL SYSTEM Ebi, L.P. | NKB |
| Jun 23, 2006 | K061520 | VIPER SPINE SYSTEM Depuy Spine, Inc. | NKB |
| May 19, 2006 | K060979 | XIA TITANIUM AND 4.5 SPINAL SYSTEMS Stryker Spine | NKB |
| Apr 26, 2006 | K060990 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM Endius, Inc. | NKB |
| Apr 13, 2006 | K060748 | MODIFICATION TO XIA 4.5 SPINAL SYSTEM Stryker Spine | NKB |
| Mar 6, 2006 | K060361 | XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM Stryker Spine | NKB |
| Feb 13, 2006 | K060203 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Jan 6, 2006 | K053474 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Jan 5, 2006 | K053101 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Dec 27, 2005 | K053276 | IST PEDICLE SCREW SYSTEM Innovative Spinal Technologies, Inc. | NKB |
| Dec 27, 2005 | K052385 | TANGORS POLYAXIAL SYSTEM Ulrich GmbH & Co. KG, DE | NKB |
| Dec 9, 2005 | K051275 | LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM Allez Spine, LLC | NKB |
| Dec 7, 2005 | K052151 | SYNTHES PANGEA MONOAXIAL SYSTEM Synthes Spine Co.Lp | NKB |
| Oct 28, 2005 | K052747 | MODIFICATION TO:CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Oct 21, 2005 | K052609 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Aug 31, 2005 | K052144 | TSRH SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Aug 22, 2005 | K052187 | MODIFICATION TO: CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Aug 16, 2005 | K052054 | TSRH SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Jul 21, 2005 | K051674 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | NKB |
| Jul 12, 2005 | K051663 | MALIBU SPINAL SYSTEM Seaspine, Inc. | NKB |
| Jul 6, 2005 | K051024 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Mar 24, 2005 | K050439 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | NKB |
| Mar 21, 2005 | K043488 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Feb 18, 2005 | K050282 | MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Feb 3, 2005 | K043321 | MODIFICATION TO: CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Dec 21, 2004 | K043232 | UCR SPINAL SYSTEM Seaspine | NKB |
| Dec 14, 2004 | K042962 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
| Dec 13, 2004 | K042772 | EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE Ebi, L.P. | NKB |
| Nov 23, 2004 | K042702 | SILHOUETTE SPINAL FIXATION SYSTEM Zimmer Spine, Inc. | NKB |
| Nov 22, 2004 | K042953 | MODIFICATION TO PROTEX STABILIZATION SYSTEM Globus Medical, Inc. | NKB |
| Nov 18, 2004 | K042886 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | NKB |
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