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 |
|---|---|---|---|
| Nov 9, 2007 | K071890 | ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. | MNH |
| Oct 18, 2007 | K070530 | MODIFICATION TO PASSMED SPINAL SYSTEM Medicrea Technologies | MNH |
| Sep 14, 2007 | K072282 | CAPLESS LI PEDICLE SCREW SYSTEM X-Spine Systems, Inc. | MNH |
| Jun 13, 2007 | K070933 | LOWTOP PEDICLE SCREW SYSTEM Sanacor | MNH |
| Jan 12, 2007 | K062670 | VERTIFLEX SPINAL SCREW SYSTEM Vertiflex (Tm), Incorporated | MNH |
| Nov 2, 2006 | K062174 | MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | MNH |
| Sep 26, 2006 | K061524 | ISS INTEGRATED SPINE SYSTEM Ortho Development Corp. | MNH |
| Sep 19, 2006 | K061813 | MANTIS SPINAL SYSTEM Stryker Spine | MNH |
| Sep 14, 2006 | K061577 | OVALTWIST PEDICLE SCREW SYSTEM Signus Medizintechnik GmbH | MNH |
| Sep 11, 2006 | K062196 | SFX SNAP-FIT CROSS CONNECTOR Depuy Spine, Inc. | MNH |
| Sep 5, 2006 | K061364 | PILOT POSTERIOR LUMBAR PLATING SYSTEM Life Spine | MNH |
| Sep 1, 2006 | K062317 | MODIFICATION TO NUVASIVE SPHERX II SYSTEM Nuvasive, Inc. | MNH |
| Jul 26, 2006 | K061162 | BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 Applied Spine Technologies, Inc. | MNH |
| Jul 25, 2006 | K061915 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | MNH |
| Jul 25, 2006 | K061441 | EBI 5.5 HELICAL FLANGE SPINAL SYSTEM Ebi, L.P. | MNH |
| Jul 18, 2006 | K061778 | NUVASIVE SPHERX II SYSTEM Nuvasive, Inc. | MNH |
| Jul 12, 2006 | K053623 | NFIX FUSION SYSTEM N-Spine, Inc. | MNH |
| Jul 7, 2006 | K061321 | ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX Alphatec Spine, Inc. | MNH |
| Jun 22, 2006 | K060702 | 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. | MNH |
| Jun 8, 2006 | K060118 | SSP PEDICLE SCREW SYSTEM Specialty Spine Products, LLC | MNH |
| Apr 12, 2006 | K060225 | NUVASIVE SPHERX SYSTEM Nuvasive, Inc. | MNH |
| Mar 8, 2006 | K053573 | GSS PEDICLE SCREW SYSTEM GS Medical Co., Ltd., KR | MNH |
| Feb 13, 2006 | K053070 | CONTOUR II SPINAL SYSTEM Altiva Corp. | MNH |
| Oct 26, 2005 | K051089 | GII SPINAL FIXATION SYSTEM Co-Ligne AG | MNH |
| Oct 12, 2005 | K051959 | NV CORMED SOLAS SPINAL SYSTEM Nv Cormed | MNH |
| Oct 7, 2005 | K051044 | ARCTEC SEMIRIGID PLATING SYSTEM Altiva Corp. | MNH |
| Sep 21, 2005 | K051697 | SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM Medical Device Advisory Development Group | MNH |
| Jul 27, 2005 | K050461 | XIA 4.5 SPINAL SYSTEM Stryker Spine | MNH |
| Jul 19, 2005 | K051216 | HYDRALOK SYSTEM Altiva Corp. | MNH |
| Jun 17, 2005 | K051286 | ZODIAC SPINAL FIXATION SYSTEM Alphatec/Nexmed | MNH |
| May 12, 2005 | K050471 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM Solco Biomedical Co., Ltd. | MNH |
| Mar 7, 2005 | K043578 | THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM Solco Biomedical Co., Ltd. | MNH |
| Mar 2, 2005 | K043180 | STRYKER SPINE TRIO PS Stryker Spine | MNH |
| Feb 18, 2005 | K050078 | ROC LUMBAR PLATING SYSTEM Alphatec/Nexmed | MNH |
| Feb 17, 2005 | K042928 | MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM U&I Corp., KR | MNH |
| Feb 1, 2005 | K043152 | VERTEBRON PSS PEDICLE SCREW SYSTEM Vertebron, Inc. | MNH |
| Dec 28, 2004 | K043343 | MODIFICATION TO: CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | MNH |
| Dec 1, 2004 | K043001 | MX POLYAXIAL PEDICLE SCREW Scient'X | MNH |
| Nov 23, 2004 | K042640 | UNI-THREAD SPINAL SYSTEM Spine Vision, Inc. | MNH |
| Nov 22, 2004 | K042964 | MX MONOAXIAL PEDICLE SCREW Scient'X | MNH |
| Jun 17, 2004 | K040747 | ALADYN RIGID SPINE PLATE Scient'X | MNH |
| Jun 3, 2004 | K033512 | PROCYON SPINAL SYSTEM Nas Medical Technologies, Inc. | MNH |
| May 20, 2004 | K040442 | PROTEX STABILIZATION SYSTEM Globus Medical, Inc. | MNH |
| Apr 21, 2004 | K034056 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | MNH |
| Apr 12, 2004 | K033546 | NUVASIVE SPINAL SYSTEM Nuvasive, Inc. | MNH |
| Feb 12, 2004 | K040072 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| Jan 20, 2004 | K032604 | GII SPINAL FIXATION SYSTEM Co-Ligne AG, CA | MNH |
| Dec 15, 2003 | K033322 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | MNH |
| Dec 10, 2003 | K032855 | STRYKER SPINE MAPS SYSTEM Howmedica Osteonics | MNH |
| Oct 9, 2003 | K031265 | SHIRAZ-JAVA SPINAL FIXATION SYSTEM Spine Next SA | MNH |
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