The following data is part of a premarket notification filed by Paradigm Spine with the FDA for Fortilink With Tiplus Technology.
| Device ID | K213493 |
| 510k Number | K213493 |
| Device Name: | Fortilink With TiPlus Technology |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Paradigm Spine Eisenbahnstrabe 84 Wurmlingen Baden-wurttemberg, DE 78573 |
| Contact | Jessica Jho |
| Correspondent | Jessica Jho Surgalign Spine Technologies 520 Lake Cook Rd Suite 315 Deerfield, IL 60015 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-01 |
| Decision Date | 2022-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260636678967 | K213493 | 000 |
| 04260636678936 | K213493 | 000 |