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510(k) K151615

TiTHON Staple with OsseoTi Technology by Biomet Manufacturing Corp — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2015
Date Received
June 15, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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