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510(k) K862254

WARSAW ORTHOPEDIC BONE PLATE by Warsaw Orthopedic, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1986
Date Received
June 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Warsaw Orthopedic, Inc.

  • K892877 — CRADLE, HOSPITAL BED CLOTHING (June 15, 1989)
  • K883783 — TSRH SACRAL SPINAL SCREW (April 6, 1989)
  • K883784 — TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE (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)

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