The following data is part of a premarket notification filed by Life Spine with the FDA for Modification To Life Spine Neo Anterior Cervical Plate System.
| Device ID | K062831 |
| 510k Number | K062831 |
| Device Name: | MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | LIFE SPINE 2400 HASSELL ROAD SUITE 370 Hoffman Estates, IL 60169 |
| Contact | Erin Malloy |
| Correspondent | Erin Malloy LIFE SPINE 2400 HASSELL ROAD SUITE 370 Hoffman Estates, IL 60169 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-20 |
| Decision Date | 2006-10-19 |
| Summary: | summary |