The following data is part of a premarket notification filed by Paradigm Spine, Gmbh with the FDA for Fortilink Cages With Tiplus Technology.
| Device ID | K201453 |
| 510k Number | K201453 |
| Device Name: | Fortilink Cages With TiPlus Technology |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Paradigm Spine, GmbH 505 Park Avenue, 14th Floor New York, NY 10022 |
| Contact | Alberto Jurado |
| Correspondent | Justin Eggleton MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | MAX |
| Subsequent Product Code | ODP |
| Subsequent Product Code | OVD |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2020-10-07 |