Medical Device Manufacturer · US , Mchenry , IL

Synthes (Usa) - FDA 510(k) Cleared Devices

411 submissions · 394 cleared · Since 1977

Recent clearances: DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM, SYNTHES SYNSONIC ULNA NAIL, SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE

411

Total

394

Cleared

0

Denied

FDA 510(k) Regulatory Record - Synthes (Usa) General & Plastic Surgery ✕

5 devices

1-5 of 5

Cleared Oct 05, 2005

SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS

General & Plastic Surgery · 86d

Cleared May 27, 2005

MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE

General & Plastic Surgery · 245d

Cleared Aug 27, 2004

SYNTHES (USA) TITANIUM WIRE

General & Plastic Surgery · 100d

Cleared Dec 06, 1999

SYNTHES LIGHT GUIDE

General & Plastic Surgery · 63d

Cleared Dec 18, 1998

SYNTHES SYNMESH

General & Plastic Surgery · 53d