Medical Device Manufacturer · US , Mchenry , IL

Warsaw Orthopedic, Inc. - FDA 510(k) Cleared Devices

24 submissions · 22 cleared · Since 1983

Recent clearances: CRADLE, HOSPITAL BED CLOTHING, TSRH SACRAL SPINAL SCREW, TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE

24

Total

22

Cleared

0

Denied

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

23 devices

1-12 of 23

Cleared Apr 06, 1989

TSRH SACRAL SPINAL SCREW

Orthopedic · 212d

Cleared Apr 06, 1989

TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE

Orthopedic · 212d

Cleared Mar 04, 1988

TSRH H/M HOOK HOLDER

Orthopedic · 45d

Cleared Mar 04, 1988

TSRH H/M HOOK HOLDER W/ROD MOVER

Orthopedic · 45d

Cleared Feb 18, 1988

TSRH H/M TORQUE LIMITING WRENCH

Orthopedic · 30d

Cleared Feb 18, 1988

TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD

Orthopedic · 30d

Cleared May 27, 1987

SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP

Orthopedic · 85d

Cleared May 27, 1987

SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA

Orthopedic · 85d

Cleared May 04, 1987

WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM

Orthopedic · 62d

Cleared Mar 13, 1987

SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR

Orthopedic · 10d

Cleared Mar 13, 1987

SCHULTZ MP COMPONENT PUNCH

Orthopedic · 10d

Cleared Mar 13, 1987

SCHULTZ PHALANGEAL COMPONENT DRIVER

Orthopedic · 10d