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510(k) K120578

ACCOLADE II HIP STEM by Howmedica Osteonics — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2012
Date Received
February 27, 2012
Clearance Type
Special
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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  • K113409 — S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESS (February 15, 2012)

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