The following data is part of a premarket notification filed by Life Spine with the FDA for Life Spine Facet Screw Spinal System.
| Device ID | K090865 |
| 510k Number | K090865 |
| Device Name: | LIFE SPINE FACET SCREW SPINAL SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
| Contact | Murali Audipudy |
| Correspondent | Murali Audipudy LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-06-26 |
| Summary: | summary |