This page includes the latest FDA filings for Spineway. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3013147946 |
| FEI Number | 3013147946 |
| Name | SPINEWAY USA, Inc. |
| Owner & Operator | Spineway |
| Contact Address | 7 Allee Moulin Berger Ecully FR-V Rhone-Alpes 69130 FR |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 13100 Wayzata Blvd Suite 110 Minnetonka, MN 55305 US |
| Registration Number | 3010758686 |
| FEI Number | 3010758686 |
| Name | SPINEWAY |
| Owner & Operator | Spineway |
| Contact Address | 7 Allee Moulin Berger Ecully FR-V Rhone-Alpes 69130 FR |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 7 Allee Moulin Berger Ecully Rhone-Alpes, 69130 FR |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C101519 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C101516 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C101213 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C91516 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C91213 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C81213 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C91519 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C81516 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C81519 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C71519 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C71516 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C71213 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C61519 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C61516 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C61213 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C51519 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C51516 | 2025-02-07 |
| SPINEWAY | Ayers Rock Cervical interbody fusion system AR2C51213 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F14258 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F13258 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F12258 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F11258 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F10258 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F9258 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F14254 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F8254 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F14250 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F13250 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F12250 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F11250 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F10250 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F9250 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F8250 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F7250 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F14208 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F13208 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F12208 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F11208 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F10208 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F9208 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F14204 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F13204 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F12204 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F11204 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F10204 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F9204 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F8204 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F14200 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F13200 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F12200 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F11200 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F10200 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F9200 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F8200 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F7200 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F9254 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F13254 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F12254 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F11254 | 2025-02-07 |
| SPINEWAY | TWIN PEAKS TP1F10254 | 2025-02-07 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P93 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P90 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P87 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P84 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P81 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P78 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P75 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P72 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P69 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P66 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P62 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P58 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P56 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P54 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P52 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P50 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P48 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P46 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P43 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P41 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P38 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P36 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P34 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P31 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P29 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P27 | 2023-09-18 |
| SPINEWAY | Blue Mountain Cervical Plate System BM2P24 | 2023-09-18 |
SPINEWAY | mont blanc spinal system | 2019-11-26 |
SPINEWAY | mont blanc MIS spinal system | 2019-11-26 |
SPINEWAY | mont blanc spinal system | 2019-11-26 |
SPINEWAY | mont blanc MIS spinal system | 2019-11-26 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1SC4014 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1SC4012 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1S4520 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1S4518 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1S4516 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1S4514 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1S4512 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1S4020 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1S4018 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1S4016 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1S4014 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1S4012 | 2019-04-09 |
| SPINEWAY | Blue Mountain Cervical Plate System BM1CPS | 2019-04-09 |
SPINEWAY | Ayers Rock Cervical interbody fusion system | 2017-01-13 |
Spineway | Ayers Rock Cervical Interbody Fusion System | 2017-01-12 |
SPINEWAY | Mont Blanc Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc MIS Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc Evo Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc MIS Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc Evo Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc MIS Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc Evo Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc MIS Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc Evo Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc MIS Spinal Systems | 2016-08-05 |
SPINEWAY | Mont Blanc Evo Spinal Systems | 2016-08-05 |
SPINEWAY | Twin Peaks Lumbar Interbody Fusion System | 2016-02-12 |
SPINEWAY | Twin Peaks Lumbar Interbody Fusion System | 2015-12-10 |
SPINEWAY | Blue Mountain Cervical Plate System | 2015-07-17 |
SPINEWAY | Mont Blanc Spinal System | 2015-05-12 |
SPINEWAY | Blue Mountain Cervical Plate System | 2015-05-07 |