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510(k) K953045

BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD by Biologically Oriented Prostheses — Product Code LZO

Clearance Details

Decision
SN ()
Decision Date
September 27, 1995
Date Received
June 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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  • 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)
  • K952731 — TOWNLEY ALL POLY ACETABULAR CUP (December 28, 1995)
  • K951356 — VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED (June 19, 1995)

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