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510(k) K013935

ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS by Sulzer Orthopedics, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2001
Date Received
November 28, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Sulzer Orthopedics, Inc.

  • K022985 — ASCENDENT ACETABULAR SYSTEM (December 5, 2002)
  • K021578 — NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE (August 9, 2002)
  • K020713 — MS-30 LATERAL FEMORAL STEM (May 14, 2002)
  • 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)
  • K003801 — ANATOMICAL PRESS-FIT HUMERAL STEM (February 28, 2001)

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