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510(k) K230595

OsteoCentric ACL Fixation System by OsteoCentric Technologies — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2023
Date Received
March 3, 2023
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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