FDA 510(k) Applications Submitted by Karen Sylvia

FDA 510(k) Number Submission Date Device Name Applicant
K170543 02/24/2017 VIPER PRIMEÖ Screws with Fenestrations Medos International, SARL
K170937 03/30/2017 VIPER PRIME navigated inserter Medos International, SARL
K160904 04/01/2016 Expedium Spine System, VIPER and VIPER 2 Systems MEDOS INTERNATIONAL SARL
K041069 04/26/2004 SPIRALOK ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K041075 04/26/2004 FASTIN RC ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K171425 05/15/2017 CONCORDE LIFT Medos International, SARL
K171570 05/30/2017 Additional VIPER PRIMEÖ screws with fenestrations Medos International, SARL
K942709 06/08/1994 MEDIASTINAL SILICONE DRAINS SIL-MED CORP.
K162912 10/17/2016 VIPER PRIMEÖ additions to the VIPER« System MEDOS INTERNATIONAL, SARL
K173526 11/14/2017 SENTIO MMG Gen 2 Medos International, SARL
K173537 11/15/2017 CONCORDE LIFTÖ Medos International, SARL
K960099 01/11/1996 PENROSE DRAIN MODELS 6001 - 6007 SIL-MED CORP.
K961194 03/27/1996 ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN SIL-MED CORP.
K961295 04/04/1996 SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR SIL-MED CORP.
K961392 04/11/1996 ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II SIL-MED CORP.
K972521 07/07/1997 NAVIGATOR (STYLET) 2006 SIL-MED CORP.
K151885 07/09/2015 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System DEPUY SYNTHES, Inc.
K032167 07/16/2003 BIO-INTRAFIX TIBIAL SCREW AND SHEATH MITEK WORLDWIDE
K022410 07/24/2002 SAPH-LOOP LIGATING LOOP GENZYME BIOSURGERY
K032717 09/02/2003 BIOCRYL RAPIDE INTERFERENCE SCREW MITEK WORLDWIDE
K022989 09/09/2002 RADLITE TISSUE RETRACTOR SYSTEM GENZYME BIOSURGERY
K955463 11/29/1995 GRIP-A-BOOTS SIL-MED CORP.
K926496 12/29/1992 SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN SIL-MED CORP.


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