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.
| Registration Number | 3000327445 | ||||||
| FEI Number | 3000327445 | ||||||
| Name | James Orsak | ||||||
| Owner & Operator | Pega Medical Inc. | ||||||
| Contact Address | 1111 Highway 13 Laval CA-QC Quebec H7W 5J8 CA | ||||||
| Official Correspondent |
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| US Agent |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||
| Initial Importer | N | ||||||
| Registration Expiration | 2020-04-25 | ||||||
| Registration Address | 3816 Bennett Rd East Ridge, TN 37412 US | ||||||
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-AOH290 | 2024-04-19 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-CHL280 | 2024-04-19 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-SDR260 | 2024-04-19 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-DGS210 | 2024-04-19 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-SOS270 | 2024-04-19 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-040 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-038 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-036 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-034 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-032 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-030 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-028 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-026 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-024 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-022 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-020 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-018 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A60-016 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-040 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-038 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-036 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-034 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-032 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-030 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-028 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-026 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-024 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-022 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-020 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-018 | 2023-12-04 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-A45-016 | 2023-12-04 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-GWR250-PKG6 | 2023-11-24 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-GWR250-PKG2 | 2023-11-24 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-CYE100-60 | 2023-11-24 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-CYE100-45 | 2023-11-24 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-CYE200 | 2023-11-24 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-CSIN240 | 2023-11-24 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-CSE200 | 2023-11-24 |
| Pega Medical Inc | Dr.Paleys Osteotomy System DRP-INF250 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-STD100 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-CUT100 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-INF250RENT | 2023-11-24 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-GWR250 | 2023-11-24 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HP-DRL230 | 2023-11-24 |
| Pega Medical Inc | Dr.Paleys Osteotomy System DRP-INE200 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-RESCRENT-3 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-RESCSET-3 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-RESCASE-3 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FC-WHL100 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM MR330 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM MR320 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM MR310 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FRT230 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FRT210 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM MR300 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FTRP111 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FTRP110 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FTRP109 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FTRP108 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FTRP107 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FRT220 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FRT200 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FRT-CYF150 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FRT-CYE100 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-GWR200-PKG6 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-GWR100-PKG6 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-CFL-60 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-CFL-48 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-CYE125 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-GWR200 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-GWR100 | 2023-11-24 |
| Pega Medical Inc | SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM BLT-BDR148 | 2023-11-24 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HPW150-PKG6 | 2023-11-24 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HPW150-PKG2 | 2023-11-24 |
| Pega Medical Inc | GAP ENDO-EXO MEDULLARY SYSTEM GAP-KNB200 | 2023-11-24 |
| Pega Medical Inc | HINGE PEDIATRIC PLATING SYSTEM HPW150 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-INSTSET-4 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-INSTSET-3 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-IMF250 R | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-IMF400 | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FD-IMF300 C | 2023-11-24 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FRT250 | 2023-08-16 |
| Pega Medical Inc | FASSIER-DUVAL TELESCOPIC IM SYSTEM FRT240 | 2023-08-16 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-HSH100 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-DRC157 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-DRC146 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-DRC132 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-TPR160 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-TPR145 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-EWS160 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-EWS145 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-GWS160 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-GWS145 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-CDR135 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-PLG160 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-PLG145 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-TMP100 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-GWR120 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GRO-GWR116 | 2022-12-07 |
| Pega Medical Inc | GIRO GROWTH MODULATION SYSTEM GIN-DPG300 | 2022-12-07 |
Pega Medical, Inc. | The GIRO Growth Modulation System | 2022-10-24 |
Pega Medical Inc. | Fassier-Duval Telescopic IM System | 2021-05-26 |
Pega Medical Inc. | The Simple Locking Intramedullary (Slim) System | 2020-06-24 |
James Orsak [Pega Medical Inc.] | Orthodontic Facilitator | 2020-01-15 |
James Orsak [Pega Medical Inc.] | The Y3 Locking Trochanteric Plating System | 2018-12-06 |
James Orsak [Pega Medical Inc.] | The Y3 Locking Trochanteric Plating System | 2018-12-06 |
James Orsak [Pega Medical Inc.] | THE LOCKING PEDIATRIC OSTEOTOMY PLATE (LOLLIPOP) SYSTEM | 2017-09-11 |
Pega Medical Inc. | The Locking Pediatric Osteotomy Plate (LolliPOP) System | 2017-09-08 |
PEGA MEDICAL INC. | Y3 Proximal Femoral Plate System | 2017-03-16 |
PEGA MEDICAL INC. | GAP ENDO-EXO MEDULLARY SYSTEM | 2016-11-23 |
James Orsak [Pega Medical Inc.] | SIMPLE LOCKING INTRAMEDULLARY SYSTEM | 2015-09-24 |
PEGA MEDICAL INC. | The Simple Locking IntraMedullary (SLIM) System | 2015-07-10 |
James Orsak [Pega Medical Inc.] | Free-Gliding SCFE Screw System | 2013-12-11 |
PEGA MEDICAL INC. | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) | 2013-11-27 |
James Orsak [Pega Medical Inc.] | GAP ENDO-EXO MEDULLARY SYSTEM | 2012-02-14 |
PEGA MEDICAL INC. | GAP ENDO-EXO MEDULLARY SYSTEM | 2012-01-26 |
James Orsak [Pega Medical Inc.] | Hinge Pediatric Plating System | 2009-06-26 |
James Orsak [Pega Medical Inc.] | Hinge Pediatric Plating System | 2009-06-26 |
James Orsak [Pega Medical Inc.] | Dr Paley's Osteotomy System | 2009-06-26 |
PEGA MEDICAL INC. | HINGE PEDIATRIC PLATING SYSTEM | 2009-05-20 |
James Orsak [Pega Medical Inc.] | Fassier-Duval Telescopic IM System | 2008-12-16 |
James Orsak [Pega Medical Inc.] | Fassier-Duval Telescopic IM System | 2008-12-16 |
PEGA MEDICAL INC. | FASSIER-DUVAL TELSCOPIC IM SYSTEM | 2004-08-17 |
PEGA MEDICAL INC. | FASSIRE-DUVAL TELESCOPIC IM SYSTEM | 2003-02-06 |
| NCAGE Code | L8920 | PEGA MEDICAL INC |
| CAGE Code | L8920 | PEGA MEDICAL INC |
| S.A.M. Registration | L8920 [257315713] | PEGA MEDICAL INC |