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510(k) K860074

SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS by Warsaw Orthopedic, Inc.

K860074 is an FDA 510(k) premarket notification submitted by Warsaw Orthopedic, Inc. for the device "SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS". The FDA issued a decision of Substantially Equivalent on February 11, 1986. Warsaw Orthopedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1986
Date Received
January 7, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K880212 — TSRH H/M HOOK HOLDER W/ROD MOVER (March 4, 1988)
  • K880211 — TSRH H/M HOOK HOLDER (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)

FDA data resources