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510(k) K952731

TOWNLEY ALL POLY ACETABULAR CUP by Biologically Oriented Prostheses — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1995
Date Received
June 15, 1995
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 Biologically Oriented Prostheses

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  • K992144 — BIOPRO RIMMED ACETABULAR COMPOMENT (September 22, 1999)
  • K964472 — RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT (February 3, 1997)
  • K962769 — HORIZON HIP SYSTEM (October 3, 1996)
  • K955916 — TOWNLEY TOTAL ELBOW SYSTEM (August 8, 1996)
  • K954768 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (January 18, 1996)
  • K953045 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (September 27, 1995)
  • K951356 — VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED (June 19, 1995)

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