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510(k) K241282

RibFix Titan™ Fixation System by Riverpoint Medical — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2024
Date Received
May 7, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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