The following data is part of a premarket notification filed by Intelivation Llc with the FDA for Advantage Lumbar System - Alif, Plif, Dlif, Tlif.
| Device ID | K212389 |
| 510k Number | K212389 |
| Device Name: | Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Intelivation LLC 70 Gruber Lane Saint Simons Island, GA 31522 |
| Contact | Amit Sinha |
| Correspondent | Barry Sands RQMIS Inc. 110 Haverhill Road Suite 524 Amesbury, MA 01913 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-02 |
| Decision Date | 2021-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G079AOL000932130 | K212389 | 000 |
| G079AOL070932140 | K212389 | 000 |
| G079AOL070932130 | K212389 | 000 |
| G079AOL070932120 | K212389 | 000 |
| G079AOL070932110 | K212389 | 000 |
| G079AOL070932100 | K212389 | 000 |
| G079AOL070932090 | K212389 | 000 |
| G079AOL070928150 | K212389 | 000 |
| G079AOL070928140 | K212389 | 000 |
| G079AOL070928130 | K212389 | 000 |
| G079AOL070928120 | K212389 | 000 |
| G079AOL070928110 | K212389 | 000 |
| G079AOL070928100 | K212389 | 000 |
| G079AOL070928090 | K212389 | 000 |
| G079AOL000932150 | K212389 | 000 |
| G079AOL070932150 | K212389 | 000 |
| G079AOL000928070 | K212389 | 000 |
| G079AOL000932120 | K212389 | 000 |
| G079AOL000932110 | K212389 | 000 |
| G079AOL000932100 | K212389 | 000 |
| G079AOL000932090 | K212389 | 000 |
| G079AOL000932080 | K212389 | 000 |
| G079AOL000932070 | K212389 | 000 |
| G079AOL000928150 | K212389 | 000 |
| G079AOL000928140 | K212389 | 000 |
| G079AOL000928130 | K212389 | 000 |
| G079AOL000928120 | K212389 | 000 |
| G079AOL000928110 | K212389 | 000 |
| G079AOL000928100 | K212389 | 000 |
| G079AOL000928090 | K212389 | 000 |
| G079AOL000928080 | K212389 | 000 |
| G079AOL000932140 | K212389 | 000 |