Medical Device Manufacturer · US , Greensburg , PA

Sofamor Co. - FDA 510(k) Cleared Devices

5 submissions · 2 cleared · Since 1985

5

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sofamor Co. Orthopedic ✕

5 devices

1-5 of 5

Cleared Jan 30, 1996

SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION

Orthopedic · 712d

Cleared May 15, 1995

APOFIX CERVICAL SPINE FIXATION

Orthopedic · 214d

Cleared Jun 02, 1994

SOFAMOR ORFIL SPINE FIXATION SYSTEM

Orthopedic · 288d

Cleared Dec 07, 1987

NEW C-D SYSTEM FOR SPINAL SURGERY

Orthopedic · 69d

Cleared Jan 10, 1985

ROD FOR RACHIS SURGERY

Orthopedic · 114d