The following data is part of a premarket notification filed by Spinal Stability, Llc with the FDA for Modulif-a Anterior Lumbar Interbody Fusion System.
| Device ID | K200958 |
| 510k Number | K200958 |
| Device Name: | MODULIF-A Anterior Lumbar Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spinal Stability, LLC 104 Hensley Circle Austin, TX 78738 |
| Contact | David Krueger |
| Correspondent | J.d. Webb The OrthoMedix Group, Inc 4313 W. 3800 S. West Haven, UT 84401 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-10 |
| Decision Date | 2020-08-28 |