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 |
|---|---|---|---|
| Dec 24, 1997 | K973683 | OMEGA 21 SYSTEM Ebi Electro Biology | MNH |
| Sep 19, 1997 | K972568 | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM Depuy, Inc. | MNH |
| Aug 20, 1997 | K971970 | EBI SPINELINK SYSTEM Electro-Biology, Inc. | MNH |
| Jun 25, 1997 | K970285 | AESUCLAP SOCON SPINAL SYSTEM Aesculap, Inc. | MNH |
| Jun 3, 1997 | K970950 | EASY ROD Acromed Corp. | MNH |
| May 8, 1997 | K965102 | ACROMED PEDICLE SCREW Acromed Corp. | MNH |
| Apr 9, 1997 | K964533 | EBI SPINELINK SYSTEM Electro-Biology, Inc. | MNH |
| Mar 14, 1997 | K965046 | ISOLA TWISTER CONNECTOR Acromed Corp. | MNH |
| Feb 13, 1997 | K963045 | SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM Synthes (Usa) | MNH |
| Feb 11, 1997 | K964544 | OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY Osteonics Corp. | MNH |
| Jan 17, 1997 | K964304 | OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY Osteonics Corp. | MNH |
| Jan 16, 1997 | K950099 | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM Buckman Co., Inc. | MNH |
| Jan 9, 1997 | K963357 | MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE Synthes (Usa) | MNH |
| Dec 16, 1996 | K964007 | ACROMED CABLE/WIRE PEDICLE SCREW Acromed Corp. | MNH |
| Dec 9, 1996 | K962608 | SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR Synthes (Usa) | MNH |
| Oct 22, 1996 | K962645 | ISOLA TWISTER CONNECTOR Acromed Corp. | MNH |
| Oct 2, 1996 | K962784 | ULTIUM SPINAL PLATING SYSTEM Smith & Nephew, Inc., Orthopaedic Div. | MNH |
| Sep 25, 1996 | K962757 | J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP J.B.S., S.A. | MNH |
| Sep 17, 1996 | K961572 | VERSALOK SCREW ASSEMBLY (PROPOSED NAME) Wrightmedicaltechnologyinc | MNH |
| May 3, 1996 | K960107 | DDS SPINAL SYSTEM Encore Orthopedics, Inc. | MNH |
| Apr 18, 1996 | K960451 | WEBB-MORLEY SPINE SYSTEM Buckman Co., Inc. | MNH |
| Feb 21, 1996 | K953881 | SPINE SYSTEM SACRAL PLATE J.B.S., S.A. | MNH |
| Feb 15, 1996 | K953915 | MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE) Depuy, Inc. | MNH |
| Feb 14, 1996 | K950717 | AUGMENT-T POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Feb 14, 1996 | K943827 | SPINE FIXATION Danek Medical, Inc. | MNH |
| Jan 25, 1996 | K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS Buckman Co., Inc. | MNH |
| Jan 22, 1996 | K952236 | ISOLA SYSTEM Acromed Corp. | MNH |
| Dec 13, 1995 | K952298 | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE J.B.S., S.A. | MNH |
| Nov 21, 1995 | K951266 | AMSET R-F SYSTEM Advanced Spine Technology, Inc. | MNH |
| Nov 7, 1995 | K953779 | SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM Advanced Spine Fixation Systems, Inc. | MNH |
| Nov 6, 1995 | K953778 | SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM Advanced Spine Fixation Systems, Inc. | MNH |
| Oct 30, 1995 | K953635 | TITANIUM DYNA-LOK SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Oct 3, 1995 | K953416 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF) Arcan Orthopaedic Corp. | MNH |
| Sep 8, 1995 | K953369 | STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW Advanced Spine Fixation Systems, Inc. | MNH |
| Sep 8, 1995 | K951725 | OSTEONICS SPINAL SYSTEM Osteonics Corp. | MNH |
| Sep 1, 1995 | K950865 | ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT Smith & Nephew Richards, Inc. | MNH |
| Aug 28, 1995 | K950596 | GDLH POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Aug 25, 1995 | K950955 | PARAGON POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Aug 21, 1995 | K951794 | SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM) Synthes (Usa) | MNH |
| Aug 21, 1995 | K951657 | VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S) Acromed Corp. | MNH |
| Aug 21, 1995 | K951626 | SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM Synthes (Usa) | MNH |
| Aug 14, 1995 | K936307 | DYNA-LOK ANTERIOR PLATING SYSTEM Danek Group, Inc. | MNH |
| Aug 11, 1995 | K951116 | ACROMED PEDICLE SCREW Acromed Corp. | MNH |
| Aug 11, 1995 | K950074 | WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM Wrightmedicaltechnologyinc | MNH |
| Aug 7, 1995 | K946348 | TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) Sofamor Danek USA,Inc. | MNH |
| Jul 26, 1995 | K951308 | 5.8MM DIAMETER ANCHOR SCREW Advanced Spine Fixation Systems, Inc. | MNH |
| Jul 25, 1995 | K951172 | TITANIUM LOW PROFILE CROSS BAR Advanced Spine Fixation Systems, Inc. | MNH |
| Jul 21, 1995 | K950695 | DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION Depuy Motech | MNH |
| Jul 13, 1995 | K940631 | CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM Cross Medical Products, Inc. | MNH |
| Jun 22, 1995 | K950697 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION Depuy Motech | MNH |
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