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510(k) K123924

DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS by Depuy Orthopaedics — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2013
Date Received
December 20, 2012
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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