The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Solus Anterior Lumbar Interbody Fusion (alif) System.
| Device ID | K123993 |
| 510k Number | K123993 |
| Device Name: | SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Contact | Trevor Denbo |
| Correspondent | Trevor Denbo ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844856099173 | K123993 | 000 |
| 00840967190464 | K123993 | 000 |
| 00840967190457 | K123993 | 000 |
| 00840967190440 | K123993 | 000 |
| 00840967190433 | K123993 | 000 |
| 00840967190426 | K123993 | 000 |
| 00840967190419 | K123993 | 000 |
| 00840967190402 | K123993 | 000 |
| 00840967190396 | K123993 | 000 |
| 00840967190389 | K123993 | 000 |
| 00840967190372 | K123993 | 000 |
| 00840967190365 | K123993 | 000 |
| 00840967190358 | K123993 | 000 |
| 00840967190341 | K123993 | 000 |
| 00840967190334 | K123993 | 000 |
| 00840967190327 | K123993 | 000 |
| 00840967190310 | K123993 | 000 |
| 00840967190488 | K123993 | 000 |
| 00840967190525 | K123993 | 000 |
| 00844856054387 | K123993 | 000 |
| 00844856099166 | K123993 | 000 |
| 00844856099159 | K123993 | 000 |
| 00844856099142 | K123993 | 000 |
| 00844856099135 | K123993 | 000 |
| 00844856099128 | K123993 | 000 |
| 00844856099111 | K123993 | 000 |
| 00844856099104 | K123993 | 000 |
| 00844856099098 | K123993 | 000 |
| 00844856099081 | K123993 | 000 |
| 00844856099074 | K123993 | 000 |
| 00844856099067 | K123993 | 000 |
| 00844856099050 | K123993 | 000 |
| 00844856099043 | K123993 | 000 |
| 00844856099036 | K123993 | 000 |
| 00844856099029 | K123993 | 000 |
| 00844856062719 | K123993 | 000 |
| 00840967189239 | K123993 | 000 |