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510(k) K171376

DynaNail TTC Fusion System by MedShape, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2017
Date Received
May 10, 2017
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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  • K141290 — HELICAL RIDGE PEEK INTERFERENCE SCREW (September 29, 2014)

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