Medical Device Manufacturer · US , Paoli , PA

Synthes Spine - FDA 510(k) Cleared Devices

36 submissions · 32 cleared · Since 1995

36

Total

32

Cleared

0

Denied

FDA 510(k) Regulatory Record - Synthes Spine Orthopedic ✕

34 devices

1-12 of 34

Cleared Jul 31, 2012

SYNTHES MATRIX SYSTEM

Orthopedic · 133d

Cleared Jun 14, 2012

SYNTHES SCOUT TACK FIXATION

Orthopedic · 426d

Cleared May 18, 2012

SYNTHES MATRIX SYSTEM

Orthopedic · 52d

Cleared May 14, 2012

SYNTHES USS CONNECTOR

Orthopedic · 77d

Cleared Feb 01, 2012

SYNTHES USS CONNECTORS

Orthopedic · 100d

Cleared Dec 21, 2011

Orthopedic · 70d

Cleared Nov 18, 2011

Orthopedic · 186d

Cleared Jan 05, 2011

SYNTHES 6.0 COCR AND CPT TI-3 RODS

Orthopedic · 65d

Cleared Dec 20, 2010

Orthopedic · 378d

Cleared Aug 05, 2010

MODIFICATION TO SYNTHES MATRIX SYSTEM

Orthopedic · 121d

Cleared May 13, 2010

SYNTHES T-PAL SPACER

Orthopedic · 121d

Cleared Jul 10, 2009

SYNTHES ORACLE PLATE

Orthopedic · 80d