Medical Device Manufacturer · US , Andover , MA

Smith & Nephew Inc., Endoscopy Division - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2007

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smith & Nephew Inc., Endoscopy Division Orthopedic ✕

7 devices

1-7 of 7

Cleared Jan 05, 2011

ENDOBUTTON DIRECT

Orthopedic · 90d

Cleared Nov 03, 2008

OSTEORAPTOR SUTURE ANCHOR

Orthopedic · 89d

Cleared Jul 16, 2008

ENDOBUTTON CONTINUOUS LOOP (CL)

Orthopedic · 90d

Cleared Dec 10, 2007

Orthopedic · 70d

Cleared Aug 17, 2007

BIORAPTOR 2.3 PK SUTURE ANCHOR

Orthopedic · 67d

Cleared May 16, 2007

SMITH & NEPHEW KINSA RC SUTURE ANCHOR

Orthopedic · 44d

Cleared Apr 12, 2007

ENDOBUTTON DIRECT

Orthopedic · 84d