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510(k) K870844

SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR by Warsaw Orthopedic, Inc. — Product Code HWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1987
Date Received
March 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractor
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Warsaw Orthopedic, Inc.

  • K892877 — CRADLE, HOSPITAL BED CLOTHING (June 15, 1989)
  • K883784 — TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE (April 6, 1989)
  • K883783 — TSRH SACRAL SPINAL SCREW (April 6, 1989)
  • K880211 — TSRH H/M HOOK HOLDER (March 4, 1988)
  • K880212 — TSRH H/M HOOK HOLDER W/ROD MOVER (March 4, 1988)
  • K880215 — TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD (February 18, 1988)
  • K880214 — TSRH H/M TORQUE LIMITING WRENCH (February 18, 1988)
  • K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (May 27, 1987)
  • K870842 — SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (May 27, 1987)
  • K870830 — WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM (May 4, 1987)

Other clearances for product code HWB

  • K873710 — MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350 (November 2, 1987)
  • K870083 — FERRAY EXTRACTOR (February 26, 1987)
  • K801327 — THE EXTRACTOR I TM (June 9, 1980)
  • K780300 — HIP PLATE REMOVAL INSTRUMENT (February 28, 1978)