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510(k) K901272

ORION BLADE PLATE FOR TIBIAL OSTEOTOMY by Med-Tek Corp. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1990
Date Received
March 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
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)
  • K901451 — F-20 CEMENTED METAL-BACKED ACETABULAR CUP (August 31, 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)
  • K901240 — ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED (March 26, 1990)
  • K894978 — BACTERIAL FILTER (November 2, 1989)

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