Pega Medical Inc

FDA Filings

This page includes the latest FDA filings for Pega Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3000327445
FEI Number3000327445
NameJames Orsak
Owner & OperatorPega Medical Inc.
Contact Address1111 Highway 13
Laval CA-QC Quebec H7W 5J8 CA
Official Correspondent
  • Ariel R Dujovne
  • 1-450-6885144-241
US Agent
Importing Logistics Registration
ImporterChildren's Hospital of King's Daughters
Address601 Children's Lane
Norfolk, VA 23507 UNITED STATES
Importer TypeEND USER
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3816 Bennett Rd
East Ridge, TN 37412 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-CSF1502021-05-28
Pega Medical Inc.
Fassier-Duval Telescopic IM System2021-05-26
Pega Medical Inc
The Locking Pediatric Osteotomy Plate (LolliPOP) System POP-IB-452021-04-22
Pega Medical Inc
The Locking Pediatric Osteotomy Plate (LolliPOP) System POP-IB-402021-04-22
Pega Medical Inc
The Locking Pediatric Osteotomy Plate (LolliPOP) System POP-CB-602021-04-22
Pega Medical Inc
The Locking Pediatric Osteotomy Plate (LolliPOP) System POP-CB-552021-04-22
Pega Medical Inc
Dr.Paleys Osteotomy System DRPFO-1072021-04-22
Pega Medical Inc
Dr.Paleys Osteotomy System DRPFO-1062021-04-22
Pega Medical Inc
Dr.Paleys Osteotomy System DRPFO-1052021-04-22
Pega Medical Inc
Dr.Paleys Osteotomy System DRPFO-1042021-04-22
Pega Medical Inc
Dr.Paleys Osteotomy System DRPFO-1032021-04-22
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM GIN-DPG2002021-04-07
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM GIN-DPG2002021-04-07
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM GIN-TRX8002021-04-07
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM GIN-TRX6002021-04-07
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM GIN-AOH1002021-04-07
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM GIN-AOH1002021-04-07
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM GIN-TRX8002021-04-07
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM GIN-TRX6002021-04-07
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CFL-282021-04-05
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CFL-242021-04-05
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CFL-202021-04-05
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CSF250-RENT2021-04-05
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CSF2502021-04-05
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-CEM-602021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-CEM-482021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-CSFRENT2021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-CSF1752021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-CSF2502021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-CSFRENT2021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-CSF1752021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-CEM-282021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-CEM-242021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-CEM-202021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-CSE1002021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-CSE1002021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-PGD1282021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-PGD1242021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-PGD1202021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-AOH1002021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-RSH1002021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-GWS1002021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-AXH1002021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-BDR1602021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-BLD1002021-04-02
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-BKY1002021-04-02
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CSE1002021-03-31
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CEM-282021-03-31
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CEM-242021-03-31
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CEM-202021-03-31
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-PGD1282021-03-31
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-PGD1242021-03-31
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-PGD1202021-03-31
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CSFRENT2021-03-31
Pega Medical Inc
FASSIER-DUVAL TELESCOPIC IM SYSTEM PEG-CSF1752021-03-31
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-48-0402021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-48-0362021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-48-0322021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-48-0282021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-48-0242021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-48-0202021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-48-0162021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0602021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0562021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0522021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0482021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0442021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0402021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0362021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0322021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0282021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0242021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0202021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-28-0162021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0602021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0562021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0522021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0482021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0442021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0402021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0362021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0322021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0282021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0242021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0202021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-24-0162021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0602021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0562021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0522021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0482021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0442021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0402021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0362021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0322021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0282021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0242021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0202021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-20-0162021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-LCP-2802021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-LCP-2402021-03-29
Pega Medical Inc
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-LCP-2002021-03-29
Pega Medical Inc.
The Simple Locking Intramedullary (Slim) System2020-06-24
James Orsak [Pega Medical Inc.]
Orthodontic Facilitator2020-01-15
James Orsak [Pega Medical Inc.]
The Y3 Locking Trochanteric Plating System2018-12-06
James Orsak [Pega Medical Inc.]
The Y3 Locking Trochanteric Plating System2018-12-06
James Orsak [Pega Medical Inc.]
THE LOCKING PEDIATRIC OSTEOTOMY PLATE (LOLLIPOP) SYSTEM2017-09-11
Pega Medical Inc.
The Locking Pediatric Osteotomy Plate (LolliPOP) System2017-09-08
PEGA MEDICAL INC.
Y3 Proximal Femoral Plate System2017-03-16
PEGA MEDICAL INC.
GAP ENDO-EXO MEDULLARY SYSTEM2016-11-23
James Orsak [Pega Medical Inc.]
SIMPLE LOCKING INTRAMEDULLARY SYSTEM2015-09-24
PEGA MEDICAL INC.
The Simple Locking IntraMedullary (SLIM) System2015-07-10
James Orsak [Pega Medical Inc.]
Free-Gliding SCFE Screw System2013-12-11
PEGA MEDICAL INC.
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)2013-11-27
James Orsak [Pega Medical Inc.]
GAP ENDO-EXO MEDULLARY SYSTEM2012-02-14
PEGA MEDICAL INC.
GAP ENDO-EXO MEDULLARY SYSTEM2012-01-26
James Orsak [Pega Medical Inc.]
Hinge Pediatric Plating System2009-06-26
James Orsak [Pega Medical Inc.]
Hinge Pediatric Plating System2009-06-26
James Orsak [Pega Medical Inc.]
Dr Paley's Osteotomy System2009-06-26
PEGA MEDICAL INC.
HINGE PEDIATRIC PLATING SYSTEM2009-05-20
James Orsak [Pega Medical Inc.]
Fassier-Duval Telescopic IM System2008-12-16
James Orsak [Pega Medical Inc.]
Fassier-Duval Telescopic IM System2008-12-16
PEGA MEDICAL INC.
FASSIER-DUVAL TELSCOPIC IM SYSTEM2004-08-17
PEGA MEDICAL INC.
FASSIRE-DUVAL TELESCOPIC IM SYSTEM2003-02-06

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