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510(k) K102992

T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES by Howmedica Osteonics Corp. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2010
Date Received
October 8, 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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