The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Epicage Interbody Fusion Device.
| Device ID | K130548 |
| 510k Number | K130548 |
| Device Name: | EPICAGE INTERBODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Contact | Nadine Smith |
| Correspondent | Nadine Smith ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-04 |
| Decision Date | 2013-04-18 |
| Summary: | summary |