The following data is part of a premarket notification filed by Life Spine with the FDA for Sentinel Spinal System.
| Device ID | K090343 |
| 510k Number | K090343 |
| Device Name: | SENTINEL SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-10 |
| Decision Date | 2009-08-11 |
| Summary: | summary |