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510(k) K231147

Hammerdesis™ Interphalangeal Fusion System by Intelivation — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2023
Date Received
April 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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