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 |