CoLink® NeoFuse
GUDID 00810021864419
Anterior Fusion Plate, 3-Hole, Left
IN2BONES USA, LLC
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile| Primary Device ID | 00810021864419 |
| NIH Device Record Key | 3b3fce24-0da9-4981-bc6f-870412a34a39 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoLink® NeoFuse |
| Version Model Number | P20 ST223 |
| 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 | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021864419 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213069
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 | 2022-01-31 |
| Device Publish Date | 2022-01-21 |
On-Brand Devices [CoLink® NeoFuse]
| 00810021865850 | CoLink®, Ø4.5 mm VA Locking Screws, 65 mm |
| 00810021865843 | CoLink®, Ø4.5 mm VA Locking Screws, 60 mm |
| 00810021865836 | CoLink®, Ø4.5 mm VA Locking Screws, 55 mm |
| 00810021865829 | CoLink®, Ø4.5 mm VA Locking Screws, 50 mm |
| 00810021865812 | CoLink®, Ø4.5 mm VA Locking Screws, 45 mm |
| 00810021865805 | CoLink®, Ø4.5 mm VA Locking Screws, 40 mm |
| 00810021865799 | CoLink®, Ø4.5 mm VA Locking Screws, 38 mm |
| 00810021865782 | CoLink®, Ø4.5 mm VA Locking Screws, 36 mm |
| 00810021865775 | CoLink®, Ø4.5 mm VA Locking Screws, 34 mm |
| 00810021865768 | CoLink®, Ø4.5 mm VA Locking Screws, 32 mm |
| 00810021865751 | CoLink®, Ø4.5 mm VA Locking Screws, 30 mm |
| 00810021865744 | CoLink®, Ø4.5 mm VA Locking Screws, 28 mm |
| 00810021865737 | CoLink®, Ø4.5 mm VA Locking Screws, 26 mm |
| 00810021865720 | CoLink®, Ø4.5 mm VA Locking Screws, 24 mm |
| 00810021865713 | CoLink®, Ø4.5 mm VA Locking Screws, 22 mm |
| 00810021865706 | CoLink®, Ø4.5 mm VA Locking Screws, 20 mm |
| 00810021865690 | CoLink®, Ø4.5 mm VA Locking Screws, 18 mm |
| 00810021865683 | CoLink®, Ø4.5 mm VA Locking Screws, 16 mm |
| 00810021865676 | CoLink®, Ø4.5 mm Locking Screws, 65 mm |
| 00810021865669 | CoLink®, Ø4.5 mm Locking Screws, 60 mm |
| 00810021865652 | CoLink®, Ø4.5 mm Locking Screws, 55 mm |
| 00810021865645 | CoLink®, Ø4.5 mm Locking Screws, 50 mm |
| 00810021865638 | CoLink®, Ø4.5 mm Locking Screws, 45 mm |
| 00810021865621 | CoLink®, Ø4.5 mm Locking Screws, 40 mm |
| 00810021865614 | CoLink®, Ø4.5 mm Locking Screws, 38 mm |
| 00810021865607 | CoLink®, Ø4.5 mm Locking Screws, 36 mm |
| 00810021865591 | CoLink®, Ø4.5 mm Locking Screws, 34 mm |
| 00810021865584 | CoLink®, Ø4.5 mm Locking Screws, 32 mm |
| 00810021865577 | CoLink®, Ø4.5 mm Locking Screws, 30 mm |
| 00810021865560 | CoLink®, Ø4.5 mm Locking Screws, 28 mm |
| 00810021865553 | CoLink®, Ø4.5 mm Locking Screws, 26 mm |
| 00810021865546 | CoLink®, Ø4.5 mm Locking Screws, 24 mm |
| 00810021865539 | CoLink®, Ø4.5 mm Locking Screws, 22 mm |
| 00810021865522 | CoLink®, Ø4.5 mm Locking Screws, 20 mm |
| 00810021865515 | CoLink®, Ø4.5 mm Locking Screws, 18 mm |
| 00810021865508 | CoLink®, Ø4.5 mm Locking Screws, 16 mm |
| 00810021865492 | CoLink®, Ø4.5 mm Non-Locking Screws, 100 mm |
| 00810021865485 | CoLink®, Ø4.5 mm Non-Locking Screws, 95 mm |
| 00810021865478 | CoLink®, Ø4.5 mm Non-Locking Screws, 90 mm |
| 00810021865461 | CoLink®, Ø4.5 mm Non-Locking Screws, 85 mm |
| 00810021865454 | CoLink®, Ø4.5 mm Non-Locking Screws, 80 mm |
| 00810021865447 | CoLink®, Ø4.5 mm Non-Locking Screws, 75 mm |
| 00810021865430 | CoLink®, Ø4.5 mm Non-Locking Screws, 70 mm |
| 00810021865423 | CoLink®, Ø4.5 mm Non-Locking Screws, 65 mm |
| 00810021865416 | CoLink®, Ø4.5 mm Non-Locking Screws, 60 mm |
| 00810021865409 | CoLink®, Ø4.5 mm Non-Locking Screws, 55 mm |
| 00810021865393 | CoLink®, Ø4.5 mm Non-Locking Screws, 50 mm |
| 00810021865386 | CoLink®, Ø4.5 mm Non-Locking Screws, 45 mm |
| 00810021865379 | CoLink®, Ø4.5 mm Non-Locking Screws, 40 mm |
| 00810021865362 | CoLink®, Ø4.5 mm Non-Locking Screws, 38 mm |
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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