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510(k) K202935

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2020
Date Received
September 29, 2020
Clearance Type
Special
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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  • K181296 — Syntec Femoral Nail System (April 11, 2019)
  • K161327 — SYNTEC HUMERAL NAIL SYSTEM (June 8, 2017)

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