CoLink® Mfx
GUDID 00810021864587
CoLink® Mfx, 1st/2nd Lisfranc Plate, Large, Left
IN2BONES USA, LLC
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile| Primary Device ID | 00810021864587 |
| NIH Device Record Key | e9aa0868-7aaf-41e0-84c3-76949a5011dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoLink® Mfx |
| Version Model Number | C20 ST221 |
| 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 | 00810021864587 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210060
FDA Product Code
| HRS | Plate, Fixation, Bone |
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® Mfx]
| 00810021864686 | CoLink® Mfx, TN Plate, Standard |
| 00810021864679 | CoLink® Mfx, Medial Column NCM Plate, Standard |
| 00810021864662 | CoLink® Mfx, Medial Column TNC Plate, Standard |
| 00810021864655 | CoLink® Mfx, Medial Column Bridge Plate, Standard |
| 00810021864648 | CoLink® Mfx, NC Plate, Standard |
| 00810021864631 | CoLink® Mfx, 2nd/3rd Lisfranc Plate, Large |
| 00810021864624 | CoLink® Mfx, 2nd/3rd Lisfranc Plate, Small |
| 00810021864617 | CoLink® Mfx, 1st/2nd Lisfranc Plate, Small, Right |
| 00810021864600 | CoLink® Mfx, 1st/2nd Lisfranc Plate, Small, Left |
| 00810021864594 | CoLink® Mfx, 1st/2nd Lisfranc Plate, Large, Right |
| 00810021864587 | CoLink® Mfx, 1st/2nd Lisfranc Plate, Large, Left |
| 00810021864570 | CoLink® Mfx, 1st TMT Lisfranc Plate, Small, Right |
| 00810021864563 | CoLink® Mfx, 1st TMT Lisfranc Plate, Small, Left |
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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