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510(k) K123991

DEPUY CORAIL AMT HIP PROSTHESIS by Depuy France S.A.S. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2013
Date Received
December 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

Other clearances by Depuy France S.A.S.

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  • K122442 — DEPUY CTA REVERSE SHOULDER SYSTEM (September 6, 2012)
  • K120174 — DEPUT DELTA XTEND REVERSE SHOULDER (June 11, 2012)

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  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)