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510(k) K961625

QUATROLOC FEMORAL COMPONENT & HEAD by Whiteside Biomechanics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1996
Date Received
April 26, 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.

  • K033313 — QUATRO M FEMORAL COMPONENT (July 28, 2004)
  • 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)
  • K964616 — QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT (August 7, 1997)
  • K971721 — WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD (July 30, 1997)
  • K971718 — MICRO-SEAL ACETABULAR SYSTEM (July 23, 1997)

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