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510(k) K870845

WARSAW ORTHOPEDIC POINTED REAMER by Warsaw Orthopedic, Inc. — Product Code HTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1987
Date Received
March 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reamer
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)
  • 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)
  • K870842 — SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (May 27, 1987)
  • K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (May 27, 1987)
  • K870830 — WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM (May 4, 1987)

Other clearances for product code HTO

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  • K013527 — MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM (December 21, 2001)
  • K993335 — SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (June 12, 2000)
  • K954915 — FLEXIBLE INTRAMEDULLARY REAMER (December 28, 1995)
  • K903248 — COMBINATION REAMER (July 30, 1990)
  • K885100 — MCCONNELL REAMER GUIDE (January 13, 1989)
  • K862933 — ABC-1000 SMALL JOINT REAMERS (August 18, 1986)
  • K832686 — MULTIPLE MANUAL SURGICAL INSTRUMENTS (October 14, 1983)
  • K811081 — MEDULLARY CANAL SCRAPERS (April 29, 1981)