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510(k) K193660

OSSIOfiber™ Compression Screws by OSSIO , Ltd. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2020
Date Received
December 30, 2019
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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