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510(k) K160545

GAP ENDO-EXO MEDULLARY SYSTEM by Pega Medical, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2016
Date Received
February 26, 2016
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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  • K111232 — GAP ENDO-EXO MEDULLARY SYSTEM (January 26, 2012)
  • K090440 — HINGE PEDIATRIC PLATING SYSTEM (May 20, 2009)
  • K041393 — FASSIER-DUVAL TELSCOPIC IM SYSTEM (August 17, 2004)

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