Panels › Orthopedic › Product code MNH · Class 2
Orthosis, Spondylolisthesis Spinal Fixation
Regulation 888.3070
0510(k)s in 12 months (309 all time)
0recalls in 12 months (15 all time)
14recalls that name a 510(k)
Top companies in MNH
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 18 | 0 |
| Acromed Corp. | 14 | 0 |
| Depuyacromed | 13 | 0 |
| Sofamor Danek | 10 | 0 |
| Ebi, L.P. | 6 | 3 |
| Howmedica Osteonics | 9 | 0 |
| Advanced Spine Fixation Systems, Inc. | 8 | 0 |
| Stryker Spine | 4 | 3 |
| Ortho Tec, LLC | 6 | 0 |
| Solco Biomedical Co., Ltd. | 6 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 27, 2003 | K031585 | U&I, OPTIMA, SPINAL SYSTEM U&I Corp., America | MNH |
| Jun 27, 2003 | K031423 | EBI P148 SPINAL FIXATION SYSTEM Ebi, L.P. | MNH |
| Jun 27, 2003 | K023378 | ORIA CLARIS Ortho Tec, LLC | MNH |
| Jun 26, 2003 | K030581 | BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) Blackstone Medical, Inc. | MNH |
| May 13, 2003 | K031290 | MODIFICATION TO EASYS TRANSVERSE CONNECTION Scient'X USA, Inc. | MNH |
| Feb 26, 2003 | K030383 | MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS Depuyacromed | MNH |
| Feb 5, 2003 | K023994 | ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ Ortho Tec, LLC | MNH |
| Jan 28, 2003 | K024348 | MONARCH SPINE SYSTEM Depuyacromed | MNH |
| Dec 10, 2002 | K020085 | SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X Sintea Biotech, Inc. | MNH |
| Nov 13, 2002 | K023438 | MODIFICATION TO MONARCH SPINE SYSTEM Depuyacromed | MNH |
| Oct 18, 2002 | K023204 | MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM Ebi, L.P. | MNH |
| Sep 10, 2002 | K021623 | UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS Iame, Inc. | MNH |
| Jul 29, 2002 | K021881 | ENDIUS TITLE SPINAL FIXATION SYSTEM Endius, Inc. | MNH |
| Jul 23, 2002 | K020356 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM Alphatec Mfg., Inc. | MNH |
| Jul 22, 2002 | K020247 | COLORADO 2 SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| Jul 11, 2002 | K021335 | MONARCH SPINE SYSTEM Depuyacromed | MNH |
| Jun 26, 2002 | K021880 | CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) Depuyacromed | MNH |
| Jun 26, 2002 | K021879 | CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) Depuyacromed | MNH |
| Jun 20, 2002 | K013962 | EQUATION FIXATION SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| May 28, 2002 | K020699 | TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| May 8, 2002 | K021148 | MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD Depuyacromed | MNH |
| Apr 3, 2002 | K020681 | EBI OMEGA21 SPINAL FIXATION SYSTEM Ebi, L.P. | MNH |
| Apr 3, 2002 | K020674 | BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW Blackstone Medical, Inc. | MNH |
| Mar 29, 2002 | K014302 | UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM Pisharodi Surgicals, Inc. | MNH |
| Feb 15, 2002 | K020196 | MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM Sulzer Spine-Tech | MNH |
| Feb 14, 2002 | K020293 | OSTEONICS SPINAL SYSTEM Howmedica Osteonics Corp. | MNH |
| Feb 12, 2002 | K013887 | BACFIX SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | MNH |
| Feb 1, 2002 | K020245 | MODIFICATION TO ISOBAR SPINAL SYSTEM Scien'Tx USA, Inc. | MNH |
| Jan 25, 2002 | K014229 | MODIFICATION TO OPUS SPINAL SYSTEM Howmedica Osteonics Corp. | MNH |
| Jan 16, 2002 | K014137 | MODIFICATION TO EBI OMEGA 21 SYSTEM Ebi, L.P. | MNH |
| Dec 27, 2001 | K014076 | MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| Dec 5, 2001 | K013688 | MODIFICATION TO XIA SPINAL SYSTEM Howmedica Osteonics Corp. | MNH |
| Nov 16, 2001 | K013444 | ISOBAR SPINAL SYSTEM Scien'Tx USA, Inc. | MNH |
| Oct 9, 2001 | K013296 | MOSS MIAMI SPINAL SYSTEMS Depuyacromed | MNH |
| Oct 9, 2001 | K013295 | TIMX SPINAL SYSTEMS Depuyacromed | MNH |
| Oct 9, 2001 | K013294 | MONARCH SPINAL SYSTEMS Depuyacromed | MNH |
| Oct 5, 2001 | K012971 | ISOLA SPINAL SYSTEMS Depuyacromed | MNH |
| Aug 15, 2001 | K012273 | SPIRAL RADIUS 90-D SST SYSTEM United States Surgical, A Division of Tyco Healthc | MNH |
| Jul 20, 2001 | K012027 | MODIFICATION TO XIA SPINE SYSTEM Howmedica Osteonics | MNH |
| May 29, 2001 | K003733 | SCS CLOSED SCREW Ortho Tec, LLC | MNH |
| May 16, 2001 | K011182 | MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS Depuyacromed | MNH |
| May 8, 2001 | K010369 | CLARIS PLATE SYSTEM Ortho Tec, LLC | MNH |
| Apr 18, 2001 | K010845 | MODIFICATION TO OSTEONICS SPINAL SYSTEM Howmedica Osteonics Corp. | MNH |
| Apr 12, 2001 | K010742 | MOSS MIAMI 5.5MM TITANIUM PIN NUT Depuyacromed | MNH |
| Apr 11, 2001 | K010720 | TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| Apr 11, 2001 | K003463 | SOCON SPINAL SYSTEM Aesculap, Inc. | MNH |
| Apr 6, 2001 | K010776 | TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS Corin USA | MNH |
| Mar 19, 2001 | K010535 | TRIFIX SPINAL FIXATION SYSTEM Endius, Inc. | MNH |
| Feb 23, 2001 | K010249 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| Jan 2, 2001 | K003764 | MODIFICATION TO EBI SPINELINK SYSTEM Ebi, L.P. | MNH |
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