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510(k) K870848

SCHULTZ METACARPAL COMPONENT DRIVER by Warsaw Orthopedic, Inc. — Product Code HWR

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
Driver, Prosthesis
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 HWR

  • K915776 — KNEE PROSTHESIS DRIVER (June 11, 1992)
  • K875054 — ACROMED ADS BONE NAIL DRIVER (January 28, 1988)
  • K870847 — SCHULTZ PHALANGEAL COMPONENT DRIVER (March 13, 1987)