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. |
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