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510(k) K131984

SYNTHES SYNSONIC ULNA NAIL by Synthes (Usa) — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2014
Date Received
June 28, 2013
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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  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)
  • K102656 — SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM (December 20, 2010)

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