Pega Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: The GIRO Growth Modulation System, Fassier-Duval Telescopic IM System, The Simple Locking Intramedullary (Slim) System
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pega Medical, Inc. Orthopedic ✕
12 devices
Cleared
Oct 24, 2022
The GIRO Growth Modulation System
Orthopedic
273d
Cleared
May 26, 2021
Fassier-Duval Telescopic IM System
Orthopedic
28d
Cleared
Jun 24, 2020
The Simple Locking Intramedullary (Slim) System
Orthopedic
271d
Cleared
Sep 08, 2017
The Locking Pediatric Osteotomy Plate (LolliPOP) System
Orthopedic
184d
Cleared
Mar 16, 2017
Y3 Proximal Femoral Plate System
Orthopedic
139d
Cleared
Nov 23, 2016
GAP ENDO-EXO MEDULLARY SYSTEM
Orthopedic
271d
Cleared
Jul 10, 2015
The Simple Locking IntraMedullary (SLIM) System
Orthopedic
228d
Cleared
Nov 27, 2013
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
Orthopedic
180d
Cleared
Jan 26, 2012
GAP ENDO-EXO MEDULLARY SYSTEM
Orthopedic
269d
Cleared
May 20, 2009
HINGE PEDIATRIC PLATING SYSTEM
Orthopedic
89d
Cleared
Aug 17, 2004
FASSIER-DUVAL TELSCOPIC IM SYSTEM
Orthopedic
85d
Cleared
Feb 06, 2003
FASSIRE-DUVAL TELESCOPIC IM SYSTEM
Orthopedic
325d