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510(k) K240175

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) by Tigon Medical — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2024
Date Received
January 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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