510(k) K111911

CORIN OPTIMOM MODULAR HEAD by Corin USA — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2011
Date Received
July 5, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type