Pega Medical Inc.

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2038-2020Class IIIOrthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - ProdApril 3, 2020
Z-0270-2020Class IISCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical insOctober 2, 2019
Z-2278-2019Class IISLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) SystemMay 29, 2019
Z-0324-2016Class IISCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE ScrOctober 20, 2015
Z-1848-2015Class IISlipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with cataloguJune 15, 2015
Z-1546-2015Class IIFemale Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM TelescoApril 10, 2015
Z-1362-2015Class IIGAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAPFebruary 20, 2015
Z-1472-2014Class IIFassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040March 5, 2014
Z-1448-2014Class IIPega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: MFebruary 7, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K220190The GIRO Growth Modulation SystemOctober 24, 2022
K211292Fassier-Duval Telescopic IM SystemMay 26, 2021
K192710The Simple Locking Intramedullary (Slim) SystemJune 24, 2020
K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemSeptember 8, 2017
K163003Y3 Proximal Femoral Plate SystemMarch 16, 2017
K160545GAP ENDO-EXO MEDULLARY SYSTEMNovember 23, 2016
K143355The Simple Locking IntraMedullary (SLIM) SystemJuly 10, 2015
K131591FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)November 27, 2013
K111232GAP ENDO-EXO MEDULLARY SYSTEMJanuary 26, 2012
K090440HINGE PEDIATRIC PLATING SYSTEMMay 20, 2009
K041393FASSIER-DUVAL TELSCOPIC IM SYSTEMAugust 17, 2004
K020885FASSIRE-DUVAL TELESCOPIC IM SYSTEMFebruary 6, 2003