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510(k) K181296

Syntec Femoral Nail System by Syntec Scientific Corporation — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2019
Date Received
May 16, 2018
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

Other clearances by Syntec Scientific Corporation

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  • K191617 — Syntec Tibial Nail System (September 3, 2019)
  • K161327 — SYNTEC HUMERAL NAIL SYSTEM (June 8, 2017)

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