FDA 510(k) Applications Submitted by Jon Gilber

FDA 510(k) Number Submission Date Device Name Applicant
K221306 05/05/2022 SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories Gyrus ACMI, Inc.
K031276 04/22/2003 SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM SYNTHES (USA)
K131242 05/01/2013 ARDIS INTERBODY SYSTEM ZIMMER SPINE, INC
K183647 12/26/2018 SOLTIVEÖ Laser System(SOLTIVEÖ Pro SuperPulsed Laser, SOLTIVEÖ Premium SuperPulsed Laser, SOLTIVEÖLaser Fibers, and Accessories) Olympus Surgical Technologies America
K010108 01/12/2001 USS-LINE EXTENSION SYNTHES
K020152 01/17/2002 SYNTHES VERTEBRAL SPACER TI SYNTHES (USA)
K000450 02/11/2000 MODIFICATION TO SYNTHES USS SYNTHES SPINE
K000536 02/16/2000 SYNTHES ANTERIOR CSLP SYSTEM SYNTHES SPINE
K010658 03/06/2001 MODIFIED USS FRACTURE SYSTEM SYNTHES (USA)
K000742 03/07/2000 SYNTHES ANTERIOR CSLP SYSTEM SYNTHES SPINE
K970863 03/10/1997 MODIFIED USSC* POLYSORB SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K030866 03/19/2003 SYNTHES ANTERIOR CSLP SYSTEM SYNTHES (USA)
K990965 03/22/1999 SYNTHES CERVIFIX SYSTEM SYNTHES (USA)
K991089 03/31/1999 SYNTHES CERVIFIX SYSTEM SYNTHES SPINE
K011037 04/05/2001 VERTEBRAL SPACER SYNTHES (USA)
K991552 05/03/1999 SYNTHES PEDIATRIC ROD SYSTEM SYNTHES (USA)
K961997 05/22/1996 USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K081558 06/03/2008 PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC PIONEER SURGICAL TECHNOLOGY
K001864 06/20/2000 SYNTHES CERVIFIX SYSTEM SYNTHES SPINE
K011969 06/25/2001 SYNTHES CERVIFIX SYSTEM SYNTHES (USA)
K131980 06/28/2013 SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM ZIMMER SPINE, INC.
K132012 07/01/2013 TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM ZIMMER SPINE, INC.
K002517 08/15/2000 USS VAS SYNTHES (USA)
K022908 09/03/2002 POSTERIOR CABLE SCREW PIONEER SURGICAL TECHNOLOGY
K132884 09/13/2013 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM ZIMMER SPINE, INC.
K003061 10/02/2000 SYNTHES USS (10.0MM SIDE OPENING SCREWS) SYNTHES
K993314 10/04/1999 SYNTHES LIGHT GUIDE SYNTHES (USA)
K003275 10/19/2000 SYNTHES SYNMESH SPACER SYSTEM SYNTHES (USA)
K053053 10/31/2005 PACP SYSTEM PIONEER SURGICAL TECHNOLOGY
K083449 11/21/2008 E-MATRIX GRAFT BONE EXTENDER PIONEER SURGICAL TECHNOLOGY
K083663 12/10/2008 PACP PIONEER SURGICAL TECHNOLOGY
K003836 12/12/2000 SYNTHES SYNEX SPACER SYSTEM SYNTHES
K994187 12/13/1999 SYNTHES CERVIFIX SYSTEM SYNTHES (USA)
K955747 12/19/1995 USSC NONABSORBABLE SUTURES UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K984612 12/24/1998 SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM SYNTHES SPINE
K024364 12/31/2002 SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW) SYNTHES (USA)
K080026 01/04/2008 QUANTUM-MIS CANNULATED SYSTEM PIONEER SURGICAL TECHNOLOGY
K090222 01/30/2009 PIONEER LUMBAR PLATE SYSTEM PIONEER SURGICAL TECHNOLOGY
K080504 02/25/2008 PIONEER LOWTOP SPINAL ROD SYSTEM PIONEER SURGICAL TECHNOLOGY
K080518 02/25/2008 PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY
K070551 02/27/2007 MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY
K070973 04/06/2007 QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY
K061151 04/25/2006 PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) PIONEER SURGICAL TECHNOLOGY
K041167 05/04/2004 PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY
K982322 07/02/1998 SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM SYNTHES (USA)
K072187 08/06/2007 PIONEER LOWTOP SPINAL ROD SYSTEM PIONEER SURGICAL TECHNOLOGY
K992739 08/16/1999 CLICK'X SYNTHES SPINE
K982987 08/26/1998 SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM SYNTHES SPINE
K072703 09/24/2007 PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM PIONEER SURGICAL TECHNOLOGY
K983530 10/08/1998 SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM SYNTHES (USA)
K043066 11/08/2004 PIONEER ANTERIOR CERVICAL PLATE SYSTEM PIONEER SURGICAL TECHNOLOGY
K073177 11/13/2007 PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM PIONEER SURGICAL TECHNOLOGY
K073229 11/15/2007 NERVE MONITORING CABLE PIONEER SURGICAL TECHNOLOGY
K043206 11/19/2004 PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) PIONEER SURGICAL TECHNOLOGY
K984377 12/03/1998 SYNTHES SPINE CERVIFIX SYSTEM SYNTHES (USA)
K994121 12/06/1999 SMALL STATURE USS SYNTHES (USA)


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact