Zimmer Spine, Inc.
FDA Regulatory Profile
Zimmer Spine, Inc. appears in FDA public data with 3 recalls, 43 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1190-2016, Class II) was initiated on February 12, 2016. Its most recent 510(k) clearance was granted on February 16, 2016.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 43
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1190-2016 | Class II | Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments f | February 12, 2016 |
| Z-1189-2016 | Class II | Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for soli | February 12, 2016 |
| Z-1019-2016 | Class II | Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic s | February 3, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K153631 | Zimmer Virage OCT Spinal Fixation System | February 16, 2016 |
| K150896 | Vitality Spinal Fixation System | August 31, 2015 |
| K151031 | Virage OCT Spinal Fixation System | June 24, 2015 |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cer | June 18, 2015 |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix | March 20, 2015 |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System | February 12, 2015 |
| K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | October 29, 2014 |
| K141500 | OPTIO-C ANTERIOR CERVICAL SYSTEM | September 23, 2014 |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | June 2, 2014 |
| K140611 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM | May 21, 2014 |
| K133184 | ARDIS INTERBODY SYSTEM | January 30, 2014 |
| K133164 | DYNESYS TOP-LOADING SPINAL SYSTEM | January 16, 2014 |
| K132894 | OPTIO-C ANTERIOR CERVICAL SYSTEM | January 16, 2014 |
| K132790 | INFIX ANTERIOR LUMBAR SYSTEM | December 20, 2013 |
| K133291 | ST360 DEGREES SPINAL FIXATION SYSTEM | December 17, 2013 |
| K133086 | TITLE 2 POLYAXIAL SPINAL SYSTEM | November 27, 2013 |
| K132884 | PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM | November 25, 2013 |
| K131980 | SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM | September 4, 2013 |
| K131242 | ARDIS INTERBODY SYSTEM | September 3, 2013 |
| K132012 | TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM | August 29, 2013 |