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510(k) K111936

ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD by Ortho Development — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2011
Date Received
July 8, 2011
Clearance Type
Special
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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