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510(k) K964616

QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT by Whiteside Biomechanics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1997
Date Received
October 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Whiteside Biomechanics, Inc.

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  • K012800 — SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM (May 3, 2002)
  • K003618 — WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-101 (May 23, 2001)
  • K993903 — WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 (February 14, 2000)
  • K991678 — WHITESIDE BIOMECHANICS SPINAL SYSTEM (August 12, 1999)
  • K981238 — BIPOLAR FEMORAL HEAD (August 21, 1998)
  • K973261 — WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD (November 24, 1997)
  • K971721 — WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD (July 30, 1997)
  • K971718 — MICRO-SEAL ACETABULAR SYSTEM (July 23, 1997)
  • K964150 — WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD (December 27, 1996)

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