Medical Device Manufacturer · US , Mchenry , IL

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

411 submissions · 394 cleared · Since 1977

411

Total

394

Cleared

0

Denied

FDA 510(k) Regulatory Record - Synthes (Usa) Neurology ✕

14 devices

1-14 of 14

Cleared Apr 14, 2010

SYNTHES AIR PEN DRIVE (APD) SYSTEM

Neurology · 168d

Cleared Dec 18, 2007

SYNTHES (USA) 2.0MM TITANIUM T-PLATE

Neurology · 81d

Cleared Apr 13, 2006

NORIAN CRS FAST SET PUTTY

Neurology · 51d

Cleared Apr 13, 2006

NORIAN CRS BONE CEMENT

Neurology · 51d

Cleared Dec 14, 2005

SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT

Neurology · 28d

Cleared Sep 08, 2004

SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP

Neurology · 85d

Cleared Jul 08, 2004

SYNTHES (USA) CHRONOS

Neurology · 49d

Cleared Jun 21, 2004

SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS

Neurology · 192d

Cleared Aug 08, 2003

SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)

Neurology · 72d

Cleared Jul 29, 2002

RESORBABLE CRANIAL CLAMPS

Neurology · 87d

Cleared Feb 07, 2002

Neurology · 181d

Cleared Jul 20, 1999

SYNTHES CRANIAL FLAP TWIST CLAMP

Neurology · 49d

Cleared Jul 20, 1999

SYNTHES CRANIAL FLAP TUBE CLAMP

Neurology · 35d

Cleared Mar 16, 1998

SYNTHES CRANIAL SPRING CLIP (CSC)

Neurology · 126d