Fortilink™-C With TETRAfuse™ 3D Technology
Intervertebral Fusion Device With Bone Graft, Cervical
RTI Surgical, Inc.
The following data is part of a premarket notification filed by Rti Surgical, Inc. with the FDA for Fortilink™-c With Tetrafuse™ 3d Technology.
Pre-market Notification Details
| Device ID | K163673 |
| 510k Number | K163673 |
| Device Name: | Fortilink™-C With TETRAfuse™ 3D Technology |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | RTI Surgical, Inc. 11621 Research Circle Alachua, FL 32615 |
| Contact | Diana Taylor |
| Correspondent | Diana Taylor RTI Surgical, Inc. 11621 Research Circle Alachua, FL 32615 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-27 |
| Decision Date | 2017-05-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846468080464 | K163673 | 000 |
| 00846468080341 | K163673 | 000 |
| 00846468080334 | K163673 | 000 |
| 00846468080327 | K163673 | 000 |
| 00846468080310 | K163673 | 000 |
| 00846468080303 | K163673 | 000 |
| 00846468080297 | K163673 | 000 |
| 00846468080280 | K163673 | 000 |
| 00846468080273 | K163673 | 000 |
| 00846468080358 | K163673 | 000 |
| 00846468080365 | K163673 | 000 |
| 00846468080372 | K163673 | 000 |
| 00846468080457 | K163673 | 000 |
| 00846468080440 | K163673 | 000 |
| 00846468080433 | K163673 | 000 |
| 00846468080426 | K163673 | 000 |
| 00846468080419 | K163673 | 000 |
| 00846468080402 | K163673 | 000 |
| 00846468080396 | K163673 | 000 |
| 00846468080389 | K163673 | 000 |
| 00846468080204 | K163673 | 000 |
Trademark Results [Fortilink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORTILINK 87101032 5287571 Live/Registered |
Pioneer Surgical Technology, Inc. 2016-07-12 |
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