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510(k) K231493

NITINEX Memory Compression Staple by Vilex, LLC — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2023
Date Received
May 23, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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