CoLink® Sfx
GUDID 00810021864167
CoLink® Sfx K-wire 0.035in (0.9mm) x 4.0in with KLIP, Sterile
IN2BONES USA, LLC
Orthopaedic bone wire| Primary Device ID | 00810021864167 |
| NIH Device Record Key | 6ae988de-dd66-4b20-b055-91dcd99ff7b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoLink® Sfx |
| Version Model Number | K24 SS109 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021864167 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203698
FDA Product Code
| HTY | Pin, Fixation, Smooth |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-23 |
| Device Publish Date | 2021-08-13 |
On-Brand Devices [CoLink® Sfx]
| 00810021866284 | CoLink® Sfx Fixation Implants, 5-Pack, .062x9.0 inches, Single-Use, Sterile |
| 00810021866277 | CoLink® Sfx Fixation Implants, 5-Pack, .054x9.0 inches, Single-Use, Sterile |
| 00810021866260 | CoLink® Sfx Fixation Implants, 5-Pack, .054x6.0 inches, Single-Use, Sterile |
| 00810021864235 | CoLink® Sfx K-wire 0.062in (1.6mm) x 9.0in with KLIP, Sterile |
| 00810021864228 | CoLink® Sfx K-wire 0.062in (1.6mm) x 6.0in with KLIP, Sterile |
| 00810021864211 | CoLink® Sfx K-wire 0.054in (1.4mm) x 9.0in with KLIP, Sterile |
| 00810021864204 | CoLink® Sfx K-wire 0.054in (1.4mm) x 6.0in with KLIP, Sterile |
| 00810021864198 | CoLink® Sfx K-wire 0.045in (1.1mm) x 9.0in with KLIP, Sterile |
| 00810021864181 | CoLink® Sfx K-wire 0.045in (1.1mm) x 6.0in with KLIP, Sterile |
| 00810021864174 | CoLink® Sfx K-wire 0.045in (1.1mm) x 4.0in with KLIP, Sterile |
| 00810021864167 | CoLink® Sfx K-wire 0.035in (0.9mm) x 4.0in with KLIP, Sterile |
Trademark Results [CoLink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COLINK 86871790 5297174 Live/Registered |
In2Bones USA, LLC 2016-01-11 |
 COLINK 86141742 4635851 Live/Registered |
Colink Digital Technology Co., Ltd 2013-12-12 |
 COLINK 75453954 2287337 Live/Registered |
CoBank, ACB 1998-03-20 |
 COLINK 75331848 2183998 Dead/Cancelled |
Continental Link, Inc. 1997-07-28 |
 COLINK 74582317 not registered Dead/Abandoned |
Chevron Chemical Company 1994-09-30 |
 COLINK 74217580 not registered Dead/Abandoned |
Chevron Chemical Company 1991-10-28 |
 COLINK 73702298 1501129 Dead/Cancelled |
INLEX, INC. 1987-12-21 |
 COLINK 73702297 not registered Dead/Abandoned |
INLEX, INC. 1987-12-21 |
 COLINK 73702296 1530826 Dead/Cancelled |
INLEX, INC. 1987-12-21 |
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