The following data is part of a premarket notification filed by Ctl Medical Corporation with the FDA for Mondrian Alif Cage With Supplementary Fixation Plate.
| Device ID | K213641 |
| 510k Number | K213641 |
| Device Name: | MONDRIAN ALIF Cage With Supplementary Fixation Plate |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CTL Medical Corporation 4550 Excel Pkwy Ste 300 Addison, TX 75001 |
| Contact | Sean Suh |
| Correspondent | Dhaval Saraiya Omni Strategic Solutions, LLC 700 Pennsylvania Ave SE 2nd Floor Washington, DC 20003 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-18 |
| Decision Date | 2022-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841732166745 | K213641 | 000 |
| 00841732166660 | K213641 | 000 |
| 00841732166677 | K213641 | 000 |
| 00841732166684 | K213641 | 000 |
| 00841732166691 | K213641 | 000 |
| 00841732166707 | K213641 | 000 |
| 00841732166714 | K213641 | 000 |
| 00841732166721 | K213641 | 000 |
| 00841732166738 | K213641 | 000 |
| 00841732166653 | K213641 | 000 |