The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Illico Fs Facet Fixation System.
| Device ID | K123218 |
| 510k Number | K123218 |
| Device Name: | ILLICO FS FACET FIXATION SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | ALPHATEC SPINE, INC. 5830 EL CAMINO REAL Carlsbad, CA 92008 |
| Contact | Trevor Denbo |
| Correspondent | Trevor Denbo ALPHATEC SPINE, INC. 5830 EL CAMINO REAL Carlsbad, CA 92008 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-15 |
| Decision Date | 2012-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844856068711 | K123218 | 000 |
| 00844856068599 | K123218 | 000 |
| 00844856068605 | K123218 | 000 |
| 00844856068612 | K123218 | 000 |
| 00844856068629 | K123218 | 000 |
| 00844856068636 | K123218 | 000 |
| 00844856068643 | K123218 | 000 |
| 00844856068650 | K123218 | 000 |
| 00844856068667 | K123218 | 000 |
| 00844856068674 | K123218 | 000 |
| 00844856068681 | K123218 | 000 |
| 00844856068698 | K123218 | 000 |
| 00844856068704 | K123218 | 000 |
| 00844856068582 | K123218 | 000 |