The following data is part of a premarket notification filed by Qualgenix Llc with the FDA for Twin Peaks Lumbar Cage.
| Device ID | K112696 |
| 510k Number | K112696 |
| Device Name: | TWIN PEAKS LUMBAR CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | QUALGENIX LLC 1 JACK'S HILL ROAD UNIT 3E Oxford, CT 06478 |
| Contact | Richard Deslauriers |
| Correspondent | Richard Deslauriers QUALGENIX LLC 1 JACK'S HILL ROAD UNIT 3E Oxford, CT 06478 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-15 |
| Decision Date | 2012-04-18 |
| Summary: | summary |