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 2, 2016 | K162066 | Reliance Spinal Screw System Reliance Medical Systems, LLC | MNH |
| Nov 3, 2016 | K162801 | CastleLoc Spinal Fixation System L&K BIOMED Co., Ltd., KR | MNH |
| Sep 23, 2016 | K162143 | FixxSure® X-Link Innovasis, Inc. | MNH |
| Sep 21, 2016 | K161151 | Spinal fixation system Canwell Medical Co., Ltd., CN | MNH |
| Aug 30, 2016 | K162189 | ANAX 5.5 Spinal System U&I Corporation, KR | MNH |
| May 5, 2016 | K151362 | HC Spinal System Hung Chun Bio-S Co., Ltd., TW | MNH |
| Apr 21, 2016 | K153404 | Zavation Spinal System Zavation, LLC | MNH |
| Mar 2, 2016 | K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System Captiva Spine | MNH |
| Dec 11, 2015 | K143013 | Spinal Inner Fixation System Changzhou Dingjian Medical Appliance Co., Ltd., CN | MNH |
| Sep 10, 2015 | K151695 | Romeo posterior osteosynthesis system Spineart, CH | MNH |
| Jun 26, 2015 | K151116 | CapLOX II/TowerLOX Pedicle Screw System Captiva Spine | MNH |
| Apr 29, 2015 | K150283 | Republic Spine Dark Star Spinal System Republic Spine, LLC | MNH |
| Mar 25, 2015 | K142798 | PASS LP Spinal System Medicrea International SA, FR | MNH |
| Feb 25, 2015 | K143417 | ANAX 5.5 Spinal System U&I Corporation, KR | MNH |
| Feb 12, 2015 | K143377 | PedFuse Pedicle Screw System Spinefrontier, Inc. | MNH |
| Jan 30, 2015 | K142957 | Ideal pedicle screw spinal system Jiangsu Ideal Medical Science & Technology Co., Ltd., CN | MNH |
| Jan 26, 2015 | K142655 | CB PROT II Posterior Spinal System Chin Bone Technique Corp, TW | MNH |
| Jan 7, 2015 | K140359 | MAXIMIS SPINAL FIXATION SYSTEM Valorem Surgical | MNH |
| Nov 24, 2014 | K142290 | KangLi pedical screw spinal system Suzhou Kangli Orthopaedics Instrument Co., Ltd., CN | MNH |
| Sep 3, 2014 | K134011 | GENERAL SPINAL SYSTEM Changzhou Dean Medical Instrument Co, Ltd., CN | MNH |
| Jun 30, 2014 | K133575 | SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM Spinevision S.A., FR | MNH |
| Jun 26, 2014 | K141376 | INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS Nexxt Spine, LLC | MNH |
| Jun 26, 2014 | K140053 | KANGLI PEDICLE SCREW SPINAL SYSTEM Suzhou Kangli Orthopaedics Instrument Co., Ltd., CN | MNH |
| Jun 19, 2014 | K140678 | COSMOLOCK PEDICLE SCREW SYSTEM Kalitec Direct, LLC | MNH |
| May 30, 2014 | K140787 | PLS (POSTERIOR LUMBAR SYSTEM) Sintea Plustek, LLC | MNH |
| May 20, 2014 | K140948 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNH |
| May 14, 2014 | K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Spinefrontier, Inc. | MNH |
| May 7, 2014 | K133690 | TRUE SPINAL FUSSION SYSTEM Innovative Surgical Designs | MNH |
| Feb 25, 2014 | K133287 | PRESSON SPINAL FIXATION SYSTEM Nexus Spine, LLC | MNH |
| Jan 10, 2014 | K132403 | ANNEXTM ADJACENT LEVEL SYSTEM Spine Wave, Inc. | MNH |
| Dec 17, 2013 | K132218 | PERFIX ILIAC SCREW SYSTEM U&I Corporation, KR | MNH |
| Nov 25, 2013 | K132101 | ANAX 5.5 SPINAL SYSTEM U&I Corporation, KR | MNH |
| Aug 8, 2013 | K131810 | OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM Osseus Fusion Systems, LLC | MNH |
| Aug 8, 2013 | K131538 | CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM Captiva Spine | MNH |
| May 31, 2013 | K130267 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart, CH | MNH |
| Apr 12, 2013 | K122994 | INTRAMEDULLARY NAIL SYSTEM Weigao Orthopaedic Device Co., Ltd., CN | MNH |
| Mar 11, 2013 | K123487 | GSO GS1 CANNULATED SCREW SYSTEM Gold Standard Orthopaedics, LLC | MNH |
| Feb 15, 2013 | K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Spinefrontier, Inc. | MNH |
| Jan 8, 2013 | K123476 | MEGA 5.5 SPINE SYSTEM Lsk Biopartners, Inc. | MNH |
| Jan 4, 2013 | K122592 | INSTINCT JAVA SYSTEM Zimmer Spine | MNH |
| Dec 3, 2012 | K122814 | GALLEON PEDICLE SCREW SYSTEM Everest Spine, LLC | MNH |
| Oct 23, 2012 | K120832 | FORTEX PEDICLE SCREW SYSTEM X-Spine Systems, Inc. | MNH |
| Jun 27, 2012 | K121016 | RANGE SPINAL SYSTEM (MESA AND DENALI) K2m, Inc. | MNH |
| Jun 27, 2012 | K120760 | LDR SPINE SPINETUNE TL SPINAL SYSTEM Ldr Spine USA, Inc. | MNH |
| May 15, 2012 | K111940 | S 100 PEDICLE SCREW SYSTEM Renovis Surgical Technologies, LLC | MNH |
| May 9, 2012 | K120491 | DSS STABILIZATION SYSTEM-RIGID Paradigm Spine, LLC | MNH |
| May 9, 2012 | K120353 | SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM Bm Korea Co., Ltd. | MNH |
| Dec 28, 2011 | K103573 | ARTS2 SPINAL FIXATION SYSTEM Advanced Medical Technologies | MNH |
| Dec 15, 2011 | K110633 | LANCER PEDICLE SCREW SYSTEM Spinal Solutions, LLC | MNH |
| Dec 12, 2011 | K111995 | XINGTM SPINE SYSTEM Implanova Co., Ltd. | MNH |
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