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510(k) K223761

OIC Intramedullary Screw System by Orthopaedic Implant Company — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2023
Date Received
December 15, 2022
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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