INTEGRATE -C Interbody Fusion System
Happe Spine
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3027726367 | 3027726367 | HAPPE SPINE | 1 | N | 2026-01-01 | 2851 Charlevoix Dr. SE Suite 327 Grand Rapids MI US 49546 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| G2308H1FT05L100 | INTEGRATE-C - Single End Trial - Large 20x15x5mm 10deg | 616-984-0204 | xxxx@xx.xx |
| G2308H1FT05M100 | INTEGRATE-C - Single End Trial - Medium 17x14x5mm 10deg | 616-984-0204 | xxxx@xx.xx |
| G2308H1FT05S100 | INTEGRATE-C - Single End Trial - Small 15x12x5mm 10deg | 616-984-0204 | xxxx@xx.xx |
| G2308H1FT06L070 | INTEGRATE-C - Single End Trial - Large 20x15x6mm 7deg | 616-984-0204 | xxxx@xx.xx |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 319502 | 1723884255 | K222004 | INTEGRATE -C Interbody Fusion System | ODP | 2023-04-28 |
| 319502 | 1979618973 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| ODP | 1 | 2023-04-28 |
Happe Spine
2024-04-10
2024-04-10
2024-04-10
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-19
2024-02-16
2024-02-16
2024-02-16
2024-02-16
2024-02-16
2024-02-16