The following data is part of a premarket notification filed by Spineway with the FDA for Twin Peaks Lumbar Interbody Fusion System.
| Device ID | K152355 |
| 510k Number | K152355 |
| Device Name: | Twin Peaks Lumbar Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINEWAY 7 ALLEE MOULIN BERGER Ecully, FR 69130 |
| Contact | Julien Thao My |
| Correspondent | Rich Jansen Rich Jansen, Pharm.D. 11821 Bramble Cove Drive Ft. Myers, FL 33905 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-20 |
| Decision Date | 2015-12-10 |
| Summary: | summary |