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510(k) K950013

CONSENSUS(TM) ORTHOPEDIC DRILL BIT by U.S. Medical Products, Inc. — Product Code HWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1995
Date Received
January 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by U.S. Medical Products, Inc.

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  • K954818 — CONSENSUS POSTERIOR STABILIZED KNEE (May 22, 1996)
  • K953443 — CONSENSUS PCL SUBSITUTING TIBIAL INSERT (April 26, 1996)
  • K952943 — CONSENSUS ALL POLY TIBIA (April 1, 1996)
  • K960302 — CONSENSUS ACETABULAR SHELL, ALL UHMWPE (April 1, 1996)
  • K960340 — CONSENSUS APEX DOME HOLE PLUG (March 15, 1996)
  • K960151 — CONSENSUS 26MM COCRMO FEMORAL HEAD (February 21, 1996)
  • K960156 — CONSENSUS 32MM COCRMO FEMORAL HEAD (February 21, 1996)
  • K960339 — CONSENSUS 22MM COCRMO FEMORAL HEAD (February 21, 1996)
  • K955386 — CONSENSUS ZIRCONIA FEMORAL HEAD (February 20, 1996)

Other clearances for product code HWE

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  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)
  • K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (May 26, 2005)
  • K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (January 5, 2005)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (September 18, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)