Panels › Orthopedic › Product code MNI · Class 2
Orthosis, Spinal Pedicle Fixation
Regulation 888.3070
0510(k)s in 12 months (303 all time)
1recalls in 12 months (213 all time)
212recalls that name a 510(k)
Top companies in MNI
| Company | 510(k)s | Recalls |
|---|---|---|
| Valorem Surgical LLC | 0 | 144 |
| Allez Spine, LLC | 1 | 27 |
| Medtronic Sofamor Danek | 25 | 0 |
| K2m, Inc. | 15 | 0 |
| Spine Wave, Inc. | 11 | 0 |
| Blackstone Medical, Inc. | 7 | 3 |
| Stryker Spine | 7 | 2 |
| Spinal USA | 8 | 0 |
| Spinal Solutions, LLC | 0 | 8 |
| Life Spine | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 27, 2004 | K033508 | PLUS PIVOT LINK UNIVERSAL SYSTEM Spine Vision, Inc. | MNI |
| Jan 22, 2004 | K022908 | POSTERIOR CABLE SCREW Pioneer Surgical Technology | MNI |
| Dec 19, 2003 | K032219 | REVOLUTION SPINAL FIXATION SYSTEM Spinal Innovations, Inc. | MNI |
| Dec 3, 2003 | K033495 | MODIFICATION TO EQUATION FIXATION SYSTEM Medtronic Sofamor Danek, Inc. | MNI |
| Nov 20, 2003 | K032739 | UCR SPINAL SYSTEM Seaspine | MNI |
| Nov 20, 2003 | K030958 | ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS Ortho Tec, LLC | MNI |
| Nov 6, 2003 | K033271 | DYNALOK CLASSIC SPINAL SYSTEM Medtronic Sofamor Danek | MNI |
| Oct 31, 2003 | K032398 | PLUS PIVOT LINK UNIVERSAL SYSTEM Spine Vision, Inc. | MNI |
| Oct 22, 2003 | K031455 | CONKLUSION PEDICLE SCREW SYSTEM Signus Medical, LLC | MNI |
| Sep 17, 2003 | K032578 | TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNI |
| Sep 17, 2003 | K031967 | TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNI |
| Sep 11, 2003 | K031985 | SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | MNI |
| Sep 4, 2003 | K032037 | CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) Medtronic Sofamor Danek | MNI |
| Sep 3, 2003 | K031833 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | MNI |
| Aug 29, 2003 | K024313 | MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM Pisharodi Surgicals, Inc. | MNI |
| Aug 6, 2003 | K031354 | EBI OMEGA21 SPINAL FIXATION SYSTEM Ebi, L.P. | MNI |
| Jul 30, 2003 | K031381 | UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS Seaspine | MNI |
| Jun 27, 2003 | K031888 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | MNI |
| Jun 27, 2003 | K031655 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | MNI |
| May 16, 2003 | K030932 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNI |
| May 15, 2003 | K030840 | MODIFICATION TO HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNI |
| Apr 17, 2003 | K030862 | BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR Blackstone Medical, Inc. | MNI |
| Mar 24, 2003 | K022949 | SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS Synthes (Usa) | MNI |
| Mar 12, 2003 | K024096 | OPTIMA, SPINAL SYSTEM U&I Corp., America | MNI |
| Mar 6, 2003 | K030377 | MODIFICATION TO SYNTHES CERVIFIX SYSTEM Synthes (Usa) | MNI |
| Feb 5, 2003 | K030103 | SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS Depuyacromed | MNI |
| Dec 11, 2002 | K023299 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM Alphatec Mfg., Inc. | MNI |
| Nov 25, 2002 | K023644 | MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | MNI |
| Nov 13, 2002 | K022768 | AMT POLYAXIAL PEDICLE SCREW Micron Precision Engineering, Inc. | MNI |
| Sep 23, 2002 | K022271 | PLUS PIVOT LINK UNIVERSAL SYSTEM Spine Vision, Inc. | MNI |
| Sep 18, 2002 | K022778 | MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNI |
| Aug 13, 2002 | K022285 | MODIFICATION TO ISOLA SPINAL SYSTEM Depuyacromed | MNI |
| Aug 1, 2002 | K022160 | XIA SPINAL SYSTEM Howmedica Osteonics | MNI |
| Aug 1, 2002 | K021510 | UNI-T UNI-THREAD SPINAL SYSTEM Spine Vision, Inc. | MNI |
| Jul 24, 2002 | K022190 | MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM Depuyacromed | MNI |
| Jul 18, 2002 | K021275 | MICOMED POSTERIOR DOUBLEROD SYSTEM Micomed Ortho GmbH | MNI |
| Jun 20, 2002 | K020279 | FOREX CORPORATION, OPTIMA, SPINAL SYSTEM Forex Corp. | MNI |
| May 31, 2002 | K021379 | SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 Ortho Tec, LLC | MNI |
| May 3, 2002 | K021106 | MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNI |
| Apr 15, 2002 | K020517 | SYNTHES DUAL-OPENING USS Synthes (Usa) | MNI |
| Feb 13, 2002 | K013301 | UNI-T SPINAL SYSTEM Spine Vision, Inc. | MNI |
| Feb 1, 2002 | K013885 | BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS Blackstone Medical, Inc. | MNI |
| Nov 16, 2001 | K013440 | ISOBAR SPINAL SYSTEM Scien'Tx USA, Inc. | MNI |
| Nov 15, 2001 | K013431 | PASS SPINAL SYSTEM Encore Orthopedics, Inc. | MNI |
| Nov 14, 2001 | K013403 | TRI-FIX SPINAL FIXATION SYSTEM Endius, Inc. | MNI |
| Nov 7, 2001 | K013222 | SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM Depuyacromed | MNI |
| Oct 24, 2001 | K013191 | PASS SPINAL SYSTEM Encore Orthopedics, Inc. | MNI |
| Aug 7, 2001 | K011807 | SCS CLARIS SPINAL SCREWS, TYPES V,G,E Ortho Tec, LLC | MNI |
| Jul 31, 2001 | K012175 | PASS SPINAL SYSTEM Encore Orthopedics, Inc. | MNI |
| Jun 12, 2001 | K010972 | ISOLA BAND CLAMP Depuyacromed | MNI |
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