The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Solus Anterior Lumbar Interbody Fusion (alif) Spinal Spacer System.
| Device ID | K102402 |
| 510k Number | K102402 |
| Device Name: | SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Contact | Mary Stanners |
| Correspondent | Mary Stanners 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 | 2010-08-24 |
| Decision Date | 2011-03-30 |
| Summary: | summary |