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 |