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510(k) K001078

SULZER ORTHOPEDICS MS-30 FEMORAL STEM by Sulzer Orthopedics, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2000
Date Received
April 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
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)
  • 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)

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  • K210842 — VerSys Cemented Revision/Calcar (December 10, 2021)