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510(k) K061698

MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR by Life Spine — Product Code JDK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2006
Date Received
June 16, 2006
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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