Fortilink
GUDID 04260636678967
TiPlus-TC Inserter, Straight
Surgalign Spine Technologies, Inc.
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 04260636678967 |
| NIH Device Record Key | dd75c130-fd4e-4796-96a9-fb7c01c880f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortilink |
| Version Model Number | 65-TC-INSERTER |
| Company DUNS | 014520584 |
| Company Name | Surgalign Spine Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com | |
| Phone | (844) 894-7752 |
| customerservice@surgalign.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260636678967 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213493
FDA Product Code
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
[04260636678967]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-14 |
| Device Publish Date | 2022-06-06 |
On-Brand Devices [Fortilink]
| 04260636678967 | TiPlus-TC Inserter, Straight |
| 04260636678936 | Fortilink-C TiPlus Inserter, Housing |
Trademark Results [Fortilink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORTILINK 87101032 5287571 Live/Registered |
Pioneer Surgical Technology, Inc. 2016-07-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.