FDA 510(k) Applications Submitted by SeaSpine, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K111671 |
06/15/2011 |
SEASPINE MONOPOLAR PROBE SYSYEM |
SEASPINE, INC. |
| K102026 |
07/19/2010 |
SEASPINE SPACER SYSTEM |
SEASPINE, INC. |
| K112206 |
08/01/2011 |
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM |
SEASPINE, INC. |
| K061342 |
04/15/2006 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
| K051663 |
06/22/2005 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
| K051942 |
07/15/2005 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
| K052170 |
08/09/2005 |
SEASPINE VBR SYSTEM |
SEASPINE, INC. |
| K062934 |
09/28/2006 |
SIERRA |
SEASPINE, INC. |
| K080526 |
02/26/2008 |
SIERRA SYSTEM |
SEASPINE, INC. |
| K071726 |
06/25/2007 |
ZUMA |
SEASPINE, INC. |
| K092521 |
08/18/2009 |
ZUMA-C |
SEASPINE, INC. |
| K122571 |
08/23/2012 |
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM |
SEASPINE, INC. |
| K072605 |
09/17/2007 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
| K072729 |
09/26/2007 |
SIERRA |
SEASPINE, INC. |
| K083089 |
10/16/2008 |
NEWPORT SPINAL SYSTEM |
SEASPINE, INC. |
| K103297 |
11/08/2010 |
REDONDO-L |
SEASPINE, INC. |
| K083338 |
11/12/2008 |
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM |
SEASPINE, INC. |
| K130830 |
03/26/2013 |
INTEGRA LAMINOPLASTY SYSTEM |
SEASPINE, INC. |
| K082309 |
08/13/2008 |
CAMBRIA |
SEASPINE, INC. |
| K082310 |
08/13/2008 |
HOLLYWOOD, PACIFICA, REDONDO, VENTURA |
SEASPINE, INC. |
| K082926 |
10/01/2008 |
ZUMA, MODEL 55-XXXX/56-XXXX |
SEASPINE, INC. |
| K133418 |
11/07/2013 |
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM |
SEASPINE, INC. |
| K150469 |
02/23/2015 |
Integra Laminoplasty System |
SEASPINE, INC. |
| K142488 |
09/04/2014 |
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene |
SeaSpine, Inc. |
| K132859 |
09/12/2013 |
INTEGRA FACET FIXATION SYSTEM |
SEASPINE, INC. |
| K121924 |
07/02/2012 |
INTEGRA INTERSPINOUS PROCESS SYSTEM |
SEASPINE, INC. |
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