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510(k) K013527

MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM by Synthes (Usa) — Product Code HTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2001
Date Received
October 23, 2001
Clearance Type
Special
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

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Other clearances for product code HTO

  • K111437 — SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) (August 10, 2011)
  • K042899 — SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS (March 16, 2005)
  • 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)
  • 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)