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510(k) K925895

ETEX HIP REPLACEMENT SYSTEM by Etex Co. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1993
Date Received
November 16, 1992
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

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  • K091607 — ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE (November 2, 2009)
  • K090855 — EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE (September 18, 2009)
  • K090310 — EQUIVABONE (March 24, 2009)
  • K090242 — GAMMA-BSM, BETA-BSM (February 20, 2009)
  • K080329 — CAP PLUS, EQUIVABONE, CAP/DBM (April 28, 2008)
  • K063050 — CAP PLUS (November 19, 2007)

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