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510(k) K050262

U2 ACETABULAR COMPONENT by United Orthopedic Corp. — Product Code LWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2005
Date Received
February 4, 2005
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 United Orthopedic Corp.

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  • K132455 — U-MOTION II PS+ CUP (September 3, 2013)
  • K122185 — U-MOTION II ACETABULAR SYSTEM (February 22, 2013)
  • K122183 — AUGMENT AND SCREW, PSA TYPE (February 5, 2013)
  • K121777 — U2 ACETABULAR CUP, PLASMA SPRAY (July 18, 2012)
  • K111546 — U2 HIP SYSTEM (July 1, 2011)
  • K103497 — CERAMIC FEMORAL HEAD (March 4, 2011)
  • K101670 — UNITED U2 BIPOLAR IMPLANT (October 8, 2010)
  • K100981 — UNITED STEM, PSA TYPE (June 14, 2010)

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)
  • K042344 — EXCIA TOTAL HIP SYSTEM (March 16, 2005)