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510(k) K903248

COMBINATION REAMER by Onyx Medical Corp. — Product Code HTO

K903248 is an FDA 510(k) premarket notification submitted by Onyx Medical Corp. for the device "COMBINATION REAMER". The FDA issued a decision of Substantially Equivalent on July 30, 1990. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. Onyx Medical Corp. has at least 10 other 510(k) clearances on record.

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.

  • K041679 — COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT (December 16, 2004)
  • K942022 — FACE-IT SHIELD (July 8, 1994)
  • K931690 — SPOON PLATE (June 7, 1994)
  • K931680 — CANNULATED CANCELLOUS SCREW (May 4, 1994)
  • K934614 — MINI FRAGMENT PLATE (May 4, 1994)
  • K931692 — T-PLATE (May 4, 1994)
  • K931684 — EPIPHYSIS PLATE (May 4, 1994)
  • K931681 — CANNULATED NAVICULAR SCREW (April 25, 1994)
  • K931691 — STRAIGHT MINI-PLATE (April 25, 1994)
  • K934616 — CANCELLOUS BONE SCREW (April 25, 1994)

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)
  • 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)

FDA data resources