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510(k) K925420

TECHMEDICA STANDARD BIPOLAR SYSTEM by Techmedica, Inc. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1993
Date Received
October 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

Other clearances by Techmedica, Inc.

  • K933935 — CKS POROUS COATED FEMORAL COMPONENT (October 11, 1994)
  • K932017 — TECHMEDICA CONTINUUM HIP WITH HA COATING (September 1, 1994)
  • K931929 — TECHMEDICA CONTINUUM HIP SYSTEM (March 29, 1994)
  • K926387 — TECHMEDICA STANDARD CEMENTED HIP SYSTEM (February 1, 1994)
  • K923808 — MULLER STRAIGHT STEM FEMORAL PROSTHESIS (July 27, 1993)
  • K926579 — TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE (April 6, 1993)
  • K911058 — TECHMEDICA CAD/CAM CUSTOM HIP (February 23, 1993)
  • K925181 — TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP (February 5, 1993)
  • K920080 — CONTINUUM KNEE SYSTEM (September 1, 1992)
  • K921458 — TMP MICROPLATING SYSTEM (July 17, 1992)

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