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510(k) K922868

THOMPSON TYPE HIP PROTHESIS by Osteo Technology, Inc. — Product Code KWA

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 Uncemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3330
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)
  • K925301 — OTI ORTHOPEDIC FASTENER SYSTEM (March 16, 1993)
  • K922682 — AMERICANA HIP PROTHESIS (March 16, 1993)
  • K922862 — CHARNLEY TYPE HIP PROTHESIS (February 12, 1993)

Other clearances for product code KWA

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  • K121544 — DYNASTY BIOFOAM SHELL (July 30, 2012)
  • K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (May 18, 2012)
  • K113322 — CONSERVE THIN SHELL (February 3, 2012)
  • K112080 — PRESERVE HIP STEM (December 28, 2011)
  • K112150 — PROFEMUR GLADIATOR HA HIP STEM (November 23, 2011)
  • K113019 — PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (November 10, 2011)
  • K111910 — GLADIATOR HIP STEM (October 14, 2011)
  • K110836 — CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (October 7, 2011)
  • K110400 — TAPERLOC COMPLETE MICROPLASTY STEM (September 30, 2011)