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510(k) K211292

Fassier-Duval Telescopic IM System by Pega Medical, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2021
Date Received
April 28, 2021
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

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  • K160545 — GAP ENDO-EXO MEDULLARY SYSTEM (November 23, 2016)
  • K143355 — The Simple Locking IntraMedullary (SLIM) System (July 10, 2015)
  • K131591 — FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) (November 27, 2013)
  • 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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