This page includes the latest FDA filings for James Orsak. 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 |
|---|---|---|
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 |
James Orsak [Pega Medical Inc.] | SIMPLE LOCKING INTRAMEDULLARY SYSTEM | 2015-09-24 |
James Orsak [Pega Medical Inc.] | Free-Gliding SCFE Screw System | 2013-12-11 |
James Orsak [Pega Medical Inc.] | GAP ENDO-EXO MEDULLARY SYSTEM | 2012-02-14 |
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 |
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 |