Panels › Orthopedic › Product code KWQ · Class 2
Appliance, Fixation, Spinal Intervertebral Body
Regulation 888.3060
11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
Top companies in KWQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Spine | 6 | 38 |
| Alphatec Spine, Inc. | 9 | 32 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 0 | 41 |
| Zimmer, Inc. | 1 | 37 |
| Medtronic Sofamor Danek | 29 | 8 |
| Nuvasive, Inc. | 21 | 0 |
| K2m | 20 | 0 |
| Depuy Spine, Inc. | 10 | 8 |
| Blackstone Medical, Inc. | 13 | 3 |
| Globus Medical, Inc. | 15 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 2015 | K152015 | Pyrenees Cervical Plate System K2m, Inc. | KWQ |
| Jul 28, 2015 | K150759 | Hyper-C Anterior Cervical Plate System Degen Medical | KWQ |
| Jul 15, 2015 | K150700 | ACP 1 Anterior Cervical Plating System Stryker Corporation | KWQ |
| Jul 14, 2015 | K150983 | Pyrenees Cervical Plate System K2m | KWQ |
| Jul 10, 2015 | K150834 | Atrax Anterior Cervical Plating System X-Spine Systems, Inc. | KWQ |
| Jul 1, 2015 | K143688 | ASFORA ANTERIOR CERVICAL PLATE SYSTEM Medical Designs, LLC | KWQ |
| Jul 1, 2015 | K143271 | CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd., KR | KWQ |
| Jun 22, 2015 | K150666 | uNion Cervical Plate System Ulrich Medical USA | KWQ |
| Jun 11, 2015 | K141332 | Captiva Spine SmartLOX Cervical Plate System Captiva Spine | KWQ |
| May 29, 2015 | K143028 | Azure Anterior Cervical Plate System Orthofix, Inc. | KWQ |
| May 7, 2015 | K150036 | Blue Mountain Cervical Plate System Spineway, FR | KWQ |
| May 1, 2015 | K142212 | Pyrenees Cervical Plate System K2m, Inc. | KWQ |
| Apr 10, 2015 | K143706 | FortiBridge Anterior Cervical Plate System Nanovis Spine, LLC | KWQ |
| Mar 20, 2015 | K150449 | LITe Plate System Stryker Corp. | KWQ |
| Mar 20, 2015 | K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior C Zimmer Spine, Inc. | KWQ |
| Mar 20, 2015 | K143279 | LnK Anterior Cervical Plate System L&K BIOMED Co., Ltd., KR | KWQ |
| Feb 27, 2015 | K143576 | Exactech Ambassador Exactech, Inc. | KWQ |
| Jan 26, 2015 | K142237 | Aviator Anterior Cervical Plate (ACP) System Stryker Corporation | KWQ |
| Jan 21, 2015 | K143065 | NuVasive ALIF Buttress Plate System Nu Vasive, Incorporated | KWQ |
| Dec 31, 2014 | K142699 | LITe Plate System Stryker Corporation | KWQ |
| Dec 4, 2014 | K141632 | ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM Medtronic Sofamor Danek USA, Inc. | KWQ |
| Nov 18, 2014 | K142060 | TRANSOM ANTERIOR CERVICAL PLATE Neurostructures, Inc. | KWQ |
| Nov 6, 2014 | K141993 | NAKOMA ACP Alliance Partners, LLC | KWQ |
| Nov 5, 2014 | K133518 | MAXAN ANTERIOR CERVICAL PLATE SYSTEM Biomet Spine (Aka Ebi, LLC) | KWQ |
| Oct 8, 2014 | K133245 | GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM Genesys Spine | KWQ |
| Sep 23, 2014 | K141500 | OPTIO-C ANTERIOR CERVICAL SYSTEM Zimmer Spine, Inc. | KWQ |
| Sep 3, 2014 | K133911 | GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM Genesys Spine | KWQ |
| Jul 9, 2014 | K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM Medtronic Sofamor Danek, Inc. | KWQ |
| Jul 2, 2014 | K140260 | SKYHAWK LATERAL PLATE SYSTEM Orthofix, Inc. | KWQ |
| Jun 26, 2014 | K133194 | DIAMOND RATTLESNAKE SYSTEM Eminent Spine | KWQ |
| Jun 12, 2014 | K140361 | META-C CERVICAL PLATE Medacta International | KWQ |
| Jun 2, 2014 | K140234 | ASPIRON ACP SYSTEM U&I Corp., KR | KWQ |
| May 21, 2014 | K140611 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM Zimmer Spine, Inc. | KWQ |
| May 14, 2014 | K132653 | NEOPLATE SPINE ANTERIOR FIXATION SYSTEM Neoortho Productos Orthopedicos S/A | KWQ |
| Apr 25, 2014 | K140742 | RELIANCE ANTERIOR CERVICAL PLATE Reliance Medical Systems, LLC | KWQ |
| Feb 20, 2014 | K133567 | UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM Globus Medical, Inc. | KWQ |
| Dec 24, 2013 | K131521 | VELOX ANTERIOR CERVICAL PLATE SYSTEM Spinecraft, LLC | KWQ |
| Dec 23, 2013 | K132310 | ASCOT Backroads Consulting, Inc. | KWQ |
| Dec 19, 2013 | K133475 | STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS Nexxt Spine, LLC | KWQ |
| Dec 5, 2013 | K132994 | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM Corelink, LLC | KWQ |
| Nov 27, 2013 | K131025 | ARCHON ANTERIOR CERVICAL PLATE SYSTEM Nuvasive, Inc. | KWQ |
| Nov 9, 2013 | K131533 | CAYMAN MI PLATE SYSTEM K2m, Inc. | KWQ |
| Oct 8, 2013 | K132589 | ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) Life Spine, Inc. | KWQ |
| Sep 6, 2013 | K132324 | SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST Medos International SARL | KWQ |
| Sep 3, 2013 | K132366 | SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS Accel Spine | KWQ |
| Aug 29, 2013 | K132012 | TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM Zimmer Spine, Inc. | KWQ |
| Aug 29, 2013 | K131200 | ASPIRON ACP SYSTEM U&I Corporation, KR | KWQ |
| Aug 29, 2013 | K130868 | NUVASIVE DECADE LATERAL PLATE SYSTEM Nuvasive, Inc. | KWQ |
| Aug 23, 2013 | K131374 | TEMPUS(TM) CERVICAL PLATE SYSTEM Neurostructures, LLC | KWQ |
| Aug 7, 2013 | K131512 | KATIA SYSTEM Shanghai Sanyou Medical Co, Ltd. | KWQ |
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