The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Guided Lateral Interbody Fusion (glif) System.
| Device ID | K090425 |
| 510k Number | K090425 |
| Device Name: | GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-19 |
| Decision Date | 2009-05-19 |
| Summary: | summary |