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510(k) K101934

DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 by Medshape Solutions — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2011
Date Received
July 12, 2010
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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  • K083792 — WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 (March 25, 2009)

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