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510(k) K926156

REPLICA(TM) TOTAL HIP SYSTEM by Osteo Technology, Inc. — Product Code LPH

Clearance Details

Decision
SN ()
Decision Date
March 9, 1994
Date Received
December 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Osteo Technology, Inc.

  • 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)
  • K925301 — OTI ORTHOPEDIC FASTENER SYSTEM (March 16, 1993)
  • K922682 — AMERICANA HIP PROTHESIS (March 16, 1993)
  • K922862 — CHARNLEY TYPE HIP PROTHESIS (February 12, 1993)
  • K922864 — MUELLER TYPE FEMORAL STEM (February 12, 1993)

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