OrthoLink™
GUDID 00846832028740
TORNIER, INC.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | 00846832028740 |
| NIH Device Record Key | 2aa05d53-532f-45cf-ad19-693b5a9da846 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoLink™ |
| Version Model Number | COW-002-05 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832028740 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073624
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
[00846832028740]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [OrthoLink™]
| 00846832041695 | MOW-002-6 |
| 00846832041688 | MOW-002-5 |
| 00846832041671 | MOW-002-4 |
| 00846832041664 | MOW-002-3 |
| 00846832041657 | MOW-002-2 |
| 00846832039609 | MFT-002-4PLKG |
| 00846832028795 | COW-002-12 |
| 00846832028788 | COW-002-10 |
| 00846832028771 | COW-002-08 |
| 00846832028764 | COW-002-07 |
| 00846832028757 | COW-002-06 |
| 00846832028740 | COW-002-05 |
| 00846832028733 | COW-002-04 |
| 00846832028726 | COW-002-02 |
Trademark Results [OrthoLink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOLINK 85033120 3907175 Live/Registered |
OrthoHelix Surgical Designs, INc. 2010-05-07 |
 ORTHOLINK 78014638 not registered Dead/Abandoned |
ORTHO LINK 2000-06-27 |
 ORTHOLINK 77874599 not registered Dead/Abandoned |
ORTHOHELIX SURGICAL DESIGNS, INC. 2009-11-17 |
 ORTHOLINK 75153396 2202458 Dead/Cancelled |
OrthoLink, Inc. 1996-08-20 |
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