The following data is part of a premarket notification filed by Life Spine, Inc with the FDA for Plateau Spacer System Titanium.
| Device ID | K130630 |
| 510k Number | K130630 |
| Device Name: | PLATEAU SPACER SYSTEM TITANIUM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | LIFE SPINE, INC 2401 W. HASSELL RD SUITE 1535 Hoffman Estates, IL 60169 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis LIFE SPINE, INC 2401 W. HASSELL RD SUITE 1535 Hoffman Estates, IL 60169 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-08 |
| Decision Date | 2013-06-13 |
| Summary: | summary |