The following data is part of a premarket notification filed by Allure Spine L.l.c. with the FDA for Spondy Spinal Fixation System.
| Device ID | K100956 |
| 510k Number | K100956 |
| Device Name: | SPONDY SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALLURE SPINE L.L.C. 9214 SANDPIPER DRIVE Charlotte, NC 28277 |
| Contact | Julia Eller |
| Correspondent | Julia Eller ALLURE SPINE L.L.C. 9214 SANDPIPER DRIVE Charlotte, NC 28277 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-07 |
| Decision Date | 2010-07-09 |
| Summary: | summary |