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510(k) K925301

OTI ORTHOPEDIC FASTENER SYSTEM by Osteo Technology, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1993
Date Received
October 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
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)
  • K922862 — CHARNLEY TYPE HIP PROTHESIS (February 12, 1993)
  • K922864 — MUELLER TYPE FEMORAL STEM (February 12, 1993)

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