The following data is part of a premarket notification filed by Kalitec Medical, Llc with the FDA for Navagio Lumbar Cage.
| Device ID | K220902 |
| 510k Number | K220902 |
| Device Name: | Navagio Lumbar Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Kalitec Medical, LLC 618 E. South Street, Suite 500 Orlando, FL 32801 |
| Contact | Scott Winn |
| 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 | 2022-03-28 |
| Decision Date | 2022-05-27 |