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510(k) K211439

Small Bone Nailing System by Skeletal Dynamics, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2021
Date Received
May 10, 2021
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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