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510(k) K922871

UNIFIT FEMORAL STEM by Osteo Technology, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
June 4, 1992
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 Osteo Technology, Inc.

  • K926156 — REPLICA(TM) TOTAL HIP SYSTEM (March 9, 1994)
  • K922859 — ANATOMICAL TYPE KNEE SYSTEM (September 23, 1993)
  • K922869 — TOTAL CONDYLAT TYPE KNEE SYSTEM (July 13, 1993)
  • K925447 — OTI ORTHOPEDIC WIRE SYSTEM (June 29, 1993)
  • K926213 — MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM (June 17, 1993)
  • K922861 — BIOMETRIC SCREW FIXATION CUP (May 12, 1993)
  • K922870 — THREE SPIKE CUP (April 8, 1993)
  • K922682 — AMERICANA HIP PROTHESIS (March 16, 1993)
  • K925301 — OTI ORTHOPEDIC FASTENER SYSTEM (March 16, 1993)
  • K922862 — CHARNLEY TYPE HIP PROTHESIS (February 12, 1993)

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