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510(k) K170704

The Locking Pediatric Osteotomy Plate (LolliPOP) System by Pega Medical, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2017
Date Received
March 8, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Pega Medical, Inc.

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  • K211292 — Fassier-Duval Telescopic IM System (May 26, 2021)
  • K192710 — The Simple Locking Intramedullary (Slim) System (June 24, 2020)
  • K163003 — Y3 Proximal Femoral Plate System (March 16, 2017)
  • 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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