Company ยท US
Zimmer Spine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2016. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 15 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 8 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | 7 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 |
| NKG | Posterior Cervical Screw System | 2 |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 |
| FST | Light, Surgical, Fiberoptic | 1 |
| HWX | Tap, Bone | 1 |
| JDQ | Cerclage, Fixation | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 16, 2016 | K153631 | Zimmer Virage OCT Spinal Fixation System Zimmer Spine, Inc. | NKG |
| Aug 31, 2015 | K150896 | Vitality Spinal Fixation System Zimmer Spine, Inc. | NKB |
| Jun 24, 2015 | K151031 | Virage OCT Spinal Fixation System Zimmer Spine, Inc. | NKG |
| Jun 18, 2015 | K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System Zimmer Spine, Inc. | NKB |
| 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 |
| Feb 12, 2015 | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lum Zimmer Spine, Inc. | MAX |
| Oct 29, 2014 | K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM Zimmer Spine, Inc. | OWI |
| Sep 23, 2014 | K141500 | OPTIO-C ANTERIOR CERVICAL SYSTEM Zimmer Spine, Inc. | KWQ |
| Jun 2, 2014 | K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM Zimmer Spine, Inc. | KWP |
| May 21, 2014 | K140611 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM Zimmer Spine, Inc. | KWQ |
| Jan 30, 2014 | K133184 | ARDIS INTERBODY SYSTEM Zimmer Spine, Inc. | MAX |
| Jan 16, 2014 | K133164 | DYNESYS TOP-LOADING SPINAL SYSTEM Zimmer Spine, Inc. | NQP |
| Jan 16, 2014 | K132894 | OPTIO-C ANTERIOR CERVICAL SYSTEM Zimmer Spine, Inc. | OVE |
| Dec 20, 2013 | K132790 | INFIX ANTERIOR LUMBAR SYSTEM Zimmer Spine, Inc. | MAX |
| Dec 17, 2013 | K133291 | ST360 DEGREES SPINAL FIXATION SYSTEM Zimmer Spine, Inc. | NKB |
| Nov 27, 2013 | K133086 | TITLE 2 POLYAXIAL SPINAL SYSTEM Zimmer Spine, Inc. | NKB |
| Nov 25, 2013 | K132884 | PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Zimmer Spine, Inc. | NKB |
| Sep 4, 2013 | K131980 | SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM Zimmer Spine, Inc. | NKB |
| Sep 3, 2013 | K131242 | ARDIS INTERBODY SYSTEM Zimmer Spine, Inc. | MAX |
| Aug 29, 2013 | K132012 | TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM Zimmer Spine, Inc. | KWQ |
| Apr 19, 2013 | K123552 | INSTINCT JAVA SYSTEM Zimmer Spine | NKB |
| Jan 4, 2013 | K122592 | INSTINCT JAVA SYSTEM Zimmer Spine | MNH |
| Dec 7, 2012 | K122733 | V2F ANTERIOR FIXATION SYSTEM Zimmer Spine, Inc. | KWQ |
| Jul 18, 2012 | K121671 | PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Zimmer Spine, Inc. | NKB |
| Dec 16, 2011 | K113270 | INSTINCT JAVA SYSTEM Zimmer Spine | NKB |
| Nov 23, 2011 | K111119 | TRABECULAR METAL (TM) FUSION DEVICE Zimmer Spine, Inc. | ODP |
| Oct 27, 2011 | K111796 | INVIZIA ANTERIOR CERVICAL PLATE SYSTEM Zimmer Spine, Inc. | KWQ |
| Aug 26, 2011 | K111301 | INSTINCT JAVA SYSTEM Zimmer Spine | NKB |
| Aug 11, 2011 | K110348 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM Zimmer Spine | OWI |
| Sep 21, 2010 | K100845 | PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES Zimmer Spine, Inc. | NKB |
| Aug 18, 2010 | K101704 | ZIMMER DTO PIN PRESS INSTRUMENT Zimmer Spine, Inc. | NQP |
| Oct 1, 2009 | K092234 | DYNESYS TOP-LOADING SPINAL SYSTEM Zimmer Spine, Inc. | NQP |
| Jul 30, 2009 | K091190 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 Zimmer Spine, Inc. | JDQ |
| Feb 22, 2008 | K080367 | ZIMMER MIS LIGHT Zimmer Spine, Inc. | FST |
| Feb 8, 2008 | K073347 | DYNESYS TOP-LOADING SPINAL SYSTEM Zimmer Spine, Inc. | NQP |
| Oct 5, 2007 | K071880 | Optima ZS Transition Screw Zimmer Spine, Inc. | MNI |
| Oct 5, 2007 | K071879 | ZIMMER DTO IMPLANT Zimmer Spine, Inc. | NQP |
| Sep 5, 2007 | K072183 | ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600 Zimmer Spine, Inc. | NKB |
| Aug 30, 2006 | K061353 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM Zimmer Spine, Inc. | KWQ |
| Apr 6, 2006 | K060638 | DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS Zimmer Spine, Inc. | NQP |
| Mar 11, 2005 | K043565 | MODIFICATION TO DYNESYS SPINAL SYSTEM Zimmer Spine, Inc. | NQP |
| Nov 23, 2004 | K042702 | SILHOUETTE SPINAL FIXATION SYSTEM Zimmer Spine, Inc. | NKB |
| Sep 24, 2004 | K041925 | ST360 SPINAL FIXATION SYSTEM Zimmer Spine, Inc. | KWP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2016 | Zimmer Spine, Inc. Instinct Java System (IFU reference: 046WAN0000T) .
Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue. Terminated |
NKB | K111301 K113270 +2 |
| Feb 12, 2016 | Zimmer Spine, Inc. Universal Clamp System (IFU reference: SNA027-N-90001).
Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures. Terminated |
NKB | None listed |
| Feb 3, 2016 | Zimmer Spine, Inc. Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3). Terminated |
KWP | K133556 |
| Nov 16, 2006 | Zimmer Spine, Inc. Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Gui Terminated |
KWP | K022374 K041925 |
| Feb 24, 2005 | Zimmer Spine, Inc. Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Terminated |
HWX | K022344 |
| Oct 23, 2004 | Zimmer Spine, Inc. ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays. Terminated |
KWQ | None listed |