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510(k) K003269

UNICONDYLAR INTERPOSITIONAL SPACER by Sulzer Orthopedics, Inc. — Product Code HSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2001
Date Received
October 18, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
Device Class
Class II
Regulation Number
888.3590
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)

Other clearances for product code HSH

  • K073233 — ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS (January 28, 2008)
  • K053094 — ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, (February 6, 2006)
  • K033242 — KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) (December 31, 2003)
  • K022779 — OTI UNICONDULAR INTERPOSITIONAL SPACER (November 20, 2002)