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510(k) K050699

MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 by Amedica Corp. — Product Code JDK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2005
Date Received
March 18, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Cement Restrictor
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

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