Medical Device Manufacturer · FR , Lourdes

Science For Biomaterials - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2006

Recent clearances: OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5, OTIS-C PLUS, LIGAFIX INTERFACE SCREW

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Science For Biomaterials Orthopedic ✕

6 devices

1-6 of 6

Cleared Jun 03, 2014

OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5

Orthopedic · 125d

Cleared Apr 19, 2012

Orthopedic · 31d

Cleared May 06, 2009

LIGAFIX INTERFACE SCREW

Orthopedic · 29d

Cleared Jul 03, 2007

MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER

Orthopedic · 69d

Cleared Mar 29, 2007

MODIFICATION TO: LIGAFIX INTERFERENCE SCREW

Orthopedic · 36d

Cleared May 24, 2006

BIO 1-KIT BIOSORB FILLED CARTRIDGE

Orthopedic · 41d