Medical Device Manufacturer · US , Carsbad , CA

Smith and Nephew Donjoy, Inc. - FDA 510(k) Cleared Devices

15 submissions · 12 cleared · Since 1991

15

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smith and Nephew Donjoy, Inc. Orthopedic ✕

5 devices

1-5 of 5

Cleared Jun 22, 1995

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW

Orthopedic · 213d

Cleared Mar 17, 1995

TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER

Orthopedic · 79d

Cleared Feb 03, 1995

AIMS CANNULATED ACL SCREW (7MM DIAMETER)

Orthopedic · 99d

Cleared Mar 10, 1994

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW

Orthopedic · 272d

Cleared Mar 10, 1994

ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM

Orthopedic · 203d