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510(k) K180377

Fracture and Correction System by In2bones USA, LLC — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2018
Date Received
February 12, 2018
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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