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510(k) K040762

SYNTHES (USA) TIBIAL NAIL SYSTEM EX by Synthes (Usa) — Product Code JDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2004
Date Received
March 25, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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