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510(k) K253640

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System by Stryker GmbH — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2026
Date Received
November 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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