Medical Device Manufacturer · US , San Leandro , CA

Surgical Dynamics, Inc. - FDA 510(k) Cleared Devices

12 submissions · 9 cleared · Since 1989

12

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Surgical Dynamics, Inc. Orthopedic ✕

7 devices

1-7 of 7

Cleared Apr 02, 1996

SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE

Orthopedic · 91d

Cleared Oct 23, 1995

SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET

Orthopedic · 47d

Cleared Mar 29, 1994

NUCLEOTOME E KIT

Orthopedic · 391d

Cleared Feb 09, 1993

NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR

Orthopedic · 208d

Cleared Dec 19, 1991

NUCLEOTOME TISSUE ASPIRATOR/CUTTER

Orthopedic · 156d

Cleared Dec 19, 1991

NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER

Orthopedic · 86d

Cleared Oct 30, 1990

SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER

Orthopedic · 127d