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510(k) K033313

QUATRO M FEMORAL COMPONENT by Whiteside Biomechanics, Inc. — Product Code LWJ

K033313 is an FDA 510(k) premarket notification submitted by Whiteside Biomechanics, Inc. for the device "QUATRO M FEMORAL COMPONENT". The FDA issued a decision of Substantially Equivalent on July 28, 2004. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Whiteside Biomechanics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2004
Date Received
October 15, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Whiteside Biomechanics, Inc.

  • 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)
  • K964150 — WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD (December 27, 1996)

Other clearances for product code LWJ

  • K120595 — UNISYN PLUS HIP STEM (October 12, 2012)
  • K103518 — TRINITY ACETABULAR SYSTEM (March 9, 2011)
  • K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS (April 21, 2009)
  • K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD (September 9, 2008)
  • K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (January 31, 2007)
  • K062978 — U2 HIP STEM, TI PLASMA SPRAY (January 16, 2007)
  • K062383 — UNISYN HA PLASMA MODULAR HIP (December 21, 2006)
  • K061699 — EXCIA (August 18, 2006)
  • K051826 — BETACONE HIP PROSTHESIS SYSTEM (November 18, 2005)
  • K050262 — U2 ACETABULAR COMPONENT (August 15, 2005)

FDA data resources