SeaSpine Inc
FDA Regulatory Profile
SeaSpine Inc appears in FDA public data with 1 recall, 32 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1841-2014, Class II) was initiated on May 21, 2014. Its most recent 510(k) clearance was granted on August 3, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 32
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1841-2014 | Class II | Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used t | May 21, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231654 | NorthStar OCT System | August 3, 2023 |
| K150469 | Integra Laminoplasty System | March 23, 2015 |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene | December 18, 2014 |
| K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM | May 1, 2014 |
| K132859 | INTEGRA FACET FIXATION SYSTEM | November 18, 2013 |
| K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | September 4, 2013 |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | May 9, 2013 |
| K122571 | MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM | December 12, 2012 |
| K112206 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | January 25, 2012 |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | December 28, 2011 |
| K102026 | SEASPINE SPACER SYSTEM | May 12, 2011 |
| K103297 | REDONDO-L | January 27, 2011 |
| K092521 | ZUMA-C | April 13, 2010 |
| K082309 | CAMBRIA | April 9, 2009 |
| K083338 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | February 2, 2009 |
| K083089 | NEWPORT SPINAL SYSTEM | January 13, 2009 |
| K082926 | ZUMA, MODEL 55-XXXX/56-XXXX | December 22, 2008 |
| K082310 | HOLLYWOOD, PACIFICA, REDONDO, VENTURA | November 10, 2008 |
| K072729 | SIERRA | April 17, 2008 |
| K080526 | SIERRA SYSTEM | April 16, 2008 |