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 22, 2011 | K111690 | DEVINE SPINAL SYSTEM Changzhou Orthmed Medical Instrument Co., Ltd., CN | MNH |
| Sep 26, 2011 | K110497 | PASS LP SPINAL SYSTEM Medicrea International | MNH |
| Sep 21, 2011 | K111370 | ODALYS PEDICLE SCREW SYSTEM Kalitec Direct, LLC | MNH |
| Jul 21, 2011 | K111362 | REXIOUS SPINAL FIXATION SYSTEM Dio Medical Co., Ltd. | MNH |
| Jun 13, 2011 | K102458 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM Solco Biomedical Co., Ltd. | MNH |
| May 25, 2011 | K110321 | TIGER SPINE SYSTEM Corelink, LLC | MNH |
| Mar 16, 2011 | K101374 | AAXTER A3 POSTERIOR SPINAL SYSTEM Aaxter Co., Ltd., TW | MNH |
| Mar 7, 2011 | K102574 | PALLA M SPINAL SYSTEM Korea Bone Bank Co., Ltd. | MNH |
| Mar 3, 2011 | K102636 | ZENITH PEDICLE SYSTEM Apollo Spine, Inc. | MNH |
| Feb 11, 2011 | K101818 | 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. | MNH |
| Feb 9, 2011 | K103085 | VENUS BASIC SPINAL FIXATION SYSTEM L&K BIOMED Co., Ltd., KR | MNH |
| Jan 25, 2011 | K102853 | FLAMENCO SPINAL FIXATION SYSTEM Ulrich GmbH & Co. KG | MNH |
| Jan 21, 2011 | K102870 | EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM Exactech, Inc. | MNH |
| Jan 20, 2011 | K101446 | EMERALD SPINAL SYSTEM Mazor Surgical Technologies , Ltd. | MNH |
| Dec 20, 2010 | K101278 | INERTIA PEDICLE SCREW SYSTEM Nexxt Spine, LLC | MNH |
| Dec 10, 2010 | K102488 | APEX SPINE SYSTEM W/ COCR RODS Spinecraft, LLC | MNH |
| Aug 10, 2010 | K093771 | QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM Pioneer Surgical Technology | MNH |
| Jul 28, 2010 | K101678 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNH |
| Jul 22, 2010 | K100706 | VENUS BASIC SPINAL FIXATION SYSTEM L&K BIOMED Co., Ltd., KR | MNH |
| Jul 9, 2010 | K100956 | SPONDY SPINAL FIXATION SYSTEM Allure Spine LLC | MNH |
| Jun 30, 2010 | K100373 | TYCHE PEDICLE SCREW SYSTEM Kyung Won Medical Co., Ltd. | MNH |
| Jun 4, 2010 | K100605 | MIS SYSTEM Spine Wave, Inc. | MNH |
| Mar 18, 2010 | K093670 | MODIFICATION TO: OASYS SYSTEM Stryker Spine | MNH |
| Feb 12, 2010 | K100122 | MODIFICATION TO CAPSURE PS SYSTEM Spine Wave, Inc. | MNH |
| Nov 9, 2009 | K091725 | PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) U&I Corp., KR | MNH |
| Oct 28, 2009 | K092011 | NORM SPINAL SYSTEM Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar, TR | MNH |
| Oct 26, 2009 | K083077 | ULC SPINAL PEDICLE SCREW SYSTEM Otis Biotech Co., Ltd., KR | MNH |
| Sep 14, 2009 | K083567 | GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW Co-Ligne AG | MNH |
| Jul 30, 2009 | K090224 | FORTEX PEDICLE SCREW SYSTEM X-Spine Systems, Inc. | MNH |
| Jul 27, 2009 | K090477 | ALPINE PEDICLE SCREW SYSTEM Sanacor | MNH |
| Jul 24, 2009 | K091110 | SPINAL EDGE TITAN PEDICLE SCREW SYSTEM Spinal Edge, LLC | MNH |
| May 14, 2009 | K090424 | DVX SPINE SYSTEM Bk Meditech, Co., Ltd. | MNH |
| Apr 29, 2009 | K090228 | ROC LUMBAR PLATING SYSTEM Alphatec Spine, Inc. | MNH |
| Apr 7, 2009 | K083581 | LANX SPINAL FIXATION SYSTEM Lanx, Inc. | MNH |
| Mar 4, 2009 | K080611 | MESA SPINAL SYSTEM K2m, Inc. | MNH |
| Jan 30, 2009 | K081153 | NOVEL SPINAL SYSTEM Medyssey Co, Ltd. | MNH |
| Jan 22, 2009 | K083826 | LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM Allez Spine, LLC | MNH |
| Dec 17, 2008 | K081165 | ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNH |
| Dec 15, 2008 | K082509 | EOS SPINAL SYSTEM Korea Bone Bank Co., Ltd. | MNH |
| Oct 3, 2008 | K082577 | PASS LP SPINAL SYSTEM Medicrea Technologies | MNH |
| Sep 24, 2008 | K081883 | MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM Us Spine | MNH |
| Sep 23, 2008 | K082453 | 4CIS SOLAR AND APOLLON SPINE SYSTEMS Solco Biomedical Co., Ltd. | MNH |
| Jul 23, 2008 | K081331 | FIXXSURE CROSS LINK Spineworks, LLC | MNH |
| Jul 18, 2008 | K081631 | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS Sintea Biotech, Inc. | MNH |
| Jun 27, 2008 | K081041 | GPS, G SURGICAL PEDICLE SYSTEM G Surgical Co., Ltd., TH | MNH |
| Jun 27, 2008 | K080828 | MOUNTAINEER OCT SPINAL SYSTEM Depuy Spine, Inc. | MNH |
| Jun 13, 2008 | K081381 | RANGE SPINAL SYSTEM, LARGE DENALI SCREWS K2m, Inc. | MNH |
| Jun 6, 2008 | K081296 | PREFERENCE PEDICLE SCREW SYSTEM Us Spine | MNH |
| Jun 4, 2008 | K080876 | DVX SPINE SYSTEM Bk Meditech, Co., Ltd. | MNH |
| Feb 4, 2008 | K073531 | ACCIN PEDICLE SCREW SYSTEM Accelerated Innovation, LLC | MNH |
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