Panels › Orthopedic › Product code MNI · Class 2
Orthosis, Spinal Pedicle Fixation
Regulation 888.3070
0510(k)s in 12 months (303 all time)
1recalls in 12 months (213 all time)
212recalls that name a 510(k)
Top companies in MNI
| Company | 510(k)s | Recalls |
|---|---|---|
| Valorem Surgical LLC | 0 | 144 |
| Allez Spine, LLC | 1 | 27 |
| Medtronic Sofamor Danek | 25 | 0 |
| K2m, Inc. | 15 | 0 |
| Spine Wave, Inc. | 11 | 0 |
| Blackstone Medical, Inc. | 7 | 3 |
| Stryker Spine | 7 | 2 |
| Spinal USA | 8 | 0 |
| Spinal Solutions, LLC | 0 | 8 |
| Life Spine | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 12, 2017 | K171497 | Mikron Spinal Fixation System Mikron Makina Sanayi Ticaret Co. , Ltd., TR | MNI |
| Oct 4, 2016 | K160731 | LumFix Spinal Fixation Sytem CG Bio Co., Ltd., KR | MNI |
| Aug 22, 2016 | K151458 | Double Medical Universal Spine System Double Medical Technology, Inc., CN | MNI |
| Jun 29, 2016 | K153273 | MySpine Pedicle Screw Placement Guides - LP Medacta International S.A., CH | MNI |
| Apr 4, 2016 | K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System Spinevision S.A., FR | MNI |
| Apr 1, 2016 | K160320 | Premier Shandong Weigao Orthopaedic Device Co., Ltd., CN | MNI |
| Feb 26, 2016 | K160003 | Sniper (R) Spine System Spine Wave, Inc. | MNI |
| Feb 1, 2016 | K152324 | YAHUA Spinal System Beijing Weigao Yahua Artificial Joint Development Co. , Ltd., CN | MNI |
| Dec 11, 2015 | K143222 | FIREFLY Pedicle Screw Navigation Guide Mighty Oak Medical, Inc. | MNI |
| Nov 18, 2015 | K150684 | WASTON General Spinal System Changzhou Waston Medical Appliance Co., Ltd., CN | MNI |
| Sep 25, 2015 | K152132 | X-spine Pedicle Screw System X-Spine Systems, Inc. | MNI |
| Sep 24, 2015 | K151592 | Gemmed pedicle screw spinal system Suzhou Gemmed Medical Instrument Co., Ltd., CN | MNI |
| Sep 17, 2015 | K152131 | Reliance Spinal Screw System Reliance Medical Systems, LLC | MNI |
| Sep 17, 2015 | K152098 | ODALYS Pedicle Screw System Kisco International, FR | MNI |
| Aug 31, 2015 | K152174 | Sniper Spine System Spine Wave, Inc. | MNI |
| Jul 31, 2015 | K151813 | Sniper Spine System Spine Wave, Inc. | MNI |
| Jun 5, 2015 | K150294 | DPZ Pedicular Fixation System Osteomed Implantes, Ltda, BR | MNI |
| Apr 8, 2015 | K150647 | Polyscrew Pedicle Screw System New Era Orthopedics, LLC | MNI |
| Feb 10, 2015 | K150049 | PASS LP Spinal System Medicrea International, FR | MNI |
| Jan 9, 2015 | K141253 | NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM New Era Orthopaedics, LLC | MNI |
| Nov 4, 2014 | K140738 | PASS LP SPINAL SYSTEM Medicrea International, FR | MNI |
| Sep 10, 2014 | K141835 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS Spineart, CH | MNI |
| Jun 26, 2014 | K141397 | SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM Precision Spine, Inc. | MNI |
| May 23, 2014 | K132788 | MYSPINE PEDICLE SCREW PLACEMENT GUIDES Medacta International | MNI |
| Apr 29, 2014 | K140229 | GENERAL SPINAL SYSTEM Tianjin Walkman Biomaterial Co., Ltd., CN | MNI |
| Jan 27, 2014 | K133103 | AVERSION PEDICLE SCREW SYSTEM K7, LLC | MNI |
| Dec 16, 2013 | K130073 | MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS Mikron Makina Sanayi VE Ticaret Ltd. Sti. | MNI |
| Nov 20, 2013 | K132757 | EVEREST SPINAL SYSTEM K2m, Inc. | MNI |
| Oct 31, 2013 | K132280 | ALTUS SPINE PEDICLE SCREW SYSTEM Altus Partners | MNI |
| Oct 17, 2013 | K130958 | TRUE SPINAL FIXATION SYSTEM Innovative Surgical Designs | MNI |
| Oct 10, 2013 | K132412 | INERTIA MIS PEDICLE SCREW SYSTEM Nexxt Spine, LLC | MNI |
| Oct 3, 2013 | K132361 | EVEREST SPINAL SYSTEM K2m, Inc. | MNI |
| Sep 19, 2013 | K132644 | LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU Corentec Co., Ltd., KR | MNI |
| Aug 20, 2013 | K132365 | SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION Accel Spine | MNI |
| Aug 9, 2013 | K132154 | CAPSURE PS SYSTEM Spine Wave, Inc. | MNI |
| Aug 9, 2013 | K131522 | CORE PEDICLE SCREW SYSTEM Core-Nexus | MNI |
| Jul 30, 2013 | K130302 | SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT Spinevision S.A., FR | MNI |
| Jul 24, 2013 | K131343 | REFORM PEDICLE SCREW SYSTEM Spinal USA | MNI |
| Jun 20, 2013 | K130279 | REFORM PEDICLE SCREW SYSTEM Spinal USA | MNI |
| Feb 7, 2013 | K123521 | RELIANCE SPINAL SCREW SYSTEM Reliance Medical Systems, LLC | MNI |
| Nov 20, 2012 | K122931 | S-LOK PSS SYSTEM Spinal USA | MNI |
| Oct 31, 2012 | K122163 | CERTEX SPINAL IMPLANT SYSTEM X-Spine Systems, Inc. | MNI |
| Oct 16, 2012 | K122332 | TOWERLOX PEDICLE SCREW SYSTEM Captiva Spine | MNI |
| Oct 11, 2012 | K122233 | CAPSURE(R) PS SYSTEM Spine Wave, Inc. | MNI |
| Aug 15, 2012 | K121615 | 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. | MNI |
| Aug 8, 2012 | K121172 | REFORM PEDICLE SCREW SYSTEM Spinal USA | MNI |
| Jun 7, 2012 | K120646 | CAPSURE(R) PS SYSTEM Spine Wave, Inc. | MNI |
| May 25, 2012 | K120899 | RANGE SPINAL SYSTEM, UNIT ROD K2m, Inc. | MNI |
| May 23, 2012 | K120879 | LEXUS CERVICAL FIXATION SYSTEM L&K BIOMED Co., Ltd., KR | MNI |
| May 18, 2012 | K120099 | RANGE SPINAL SYSTEM (MESA AND DENALI) K2m, Inc. | MNI |
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