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510(k) K221193

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm by OSSIO , Ltd. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2022
Date Received
April 25, 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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