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510(k) K901451

F-20 CEMENTED METAL-BACKED ACETABULAR CUP by Med-Tek Corp. — Product Code JDI

Clearance Details

Decision
SN ()
Decision Date
August 31, 1990
Date Received
April 2, 1990
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 Med-Tek Corp.

  • K903234 — F-19 TOTAL HIP PROSTHESIS (October 10, 1990)
  • K901687 — F-24 FEMORAL HIP PROSTHESIS (September 7, 1990)
  • K900428 — ANESTHESIA BREATHING CIRCUITS (August 17, 1990)
  • K901626 — H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED (August 14, 1990)
  • K901594 — H.N. TOTAL HIP PROSTHESIS (August 3, 1990)
  • K901480 — F-20 TOTAL HIP PROSTHESIS (June 12, 1990)
  • K901273 — L.M.S. SELF-DETACHABLE BROACH WITH STOP (June 5, 1990)
  • K901272 — ORION BLADE PLATE FOR TIBIAL OSTEOTOMY (April 23, 1990)
  • K901240 — ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED (March 26, 1990)
  • K894978 — BACTERIAL FILTER (November 2, 1989)

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