HAPPE Spine
Matched from indexed company URL: HAPPE SPINE
FDA Registration(s)#
Registration, FEI, Name table| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|
| 3018044926 | 3018044926 | HAPPE Spine | 1 | N | 2026-01-01 | 1105 Auburn Drive Auburn IN US 46706 |
| 3027726367 | 3027726367 | HAPPE SPINE | 1 | N | 2026-01-01 | 2851 Charlevoix Dr. SE Suite 327 Grand Rapids MI US 49546 |
Registered Device Listings#
Registration key, Listing key, Premarket submission table| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|
| 319502 | 1723884255 | K222004 | INTEGRATE -C Interbody Fusion System | ODP | 2023-04-28 |
| 352529 | 1723884255 | K222004 | INTEGRATE -C Interbody Fusion System | ODP | 2023-04-28 |
| 319502 | 1979618973 | | | | |
Product Codes Associated With Registrations#
Product code, Registration listing records, Latest decision table| Product code | Registration listing records | Latest decision |
|---|
| ODP | 2 | 2023-04-28 |