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510(k) K002575

INTER-OP DURASUL ACETABULAR INSERTS (4MM) by Sulzer Orthopedics, Inc. — Product Code LWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2000
Date Received
August 18, 2000
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 Sulzer Orthopedics, Inc.

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  • K020713 — MS-30 LATERAL FEMORAL STEM (May 14, 2002)
  • K013935 — ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS (December 13, 2001)
  • K013031 — MOST OPTIONS SYSTEM (December 7, 2001)
  • K012739 — CONVERGE ACETABULAR SYSTEM (November 14, 2001)
  • K012961 — SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM (October 18, 2001)
  • K011954 — SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE (September 19, 2001)
  • K010839 — CLS VARUS STEM/CLS 135 STEM (April 18, 2001)
  • K003758 — ALLOFIT ACETABULAR SYSTEM (March 7, 2001)

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)