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510(k) K903248

COMBINATION REAMER by Onyx Medical Corp. — Product Code HTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1990
Date Received
July 24, 1990
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 Onyx Medical Corp.

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  • K931690 — SPOON PLATE (June 7, 1994)
  • K931692 — T-PLATE (May 4, 1994)
  • K931680 — CANNULATED CANCELLOUS SCREW (May 4, 1994)
  • K931684 — EPIPHYSIS PLATE (May 4, 1994)
  • K934614 — MINI FRAGMENT PLATE (May 4, 1994)
  • K931687 — MULTIPLE FRAGMENT PLATE (April 25, 1994)
  • K931685 — FOREARM SELF COMPRESSION PLATE (April 25, 1994)
  • K931688 — SEMI-TUBULAR PLATE (April 25, 1994)

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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)
  • K885100 — MCCONNELL REAMER GUIDE (January 13, 1989)
  • K870845 — WARSAW ORTHOPEDIC POINTED REAMER (March 11, 1987)
  • K862933 — ABC-1000 SMALL JOINT REAMERS (August 18, 1986)
  • K832686 — MULTIPLE MANUAL SURGICAL INSTRUMENTS (October 14, 1983)
  • K811081 — MEDULLARY CANAL SCRAPERS (April 29, 1981)