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510(k) K241359

Medline UNITE® MIS Foot Recon Screw System by Medline Industries, LP — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2024
Date Received
May 14, 2024
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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