Nex-Link OCT® 7001-01
GUDID 00889024337855
BIOMET SPINE LLC
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00889024337855 |
| NIH Device Record Key | e4f5149c-af8b-427c-837a-e2e59a3af7c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nex-Link OCT® |
| Version Model Number | 7001-01 |
| Catalog Number | 7001-01 |
| Company DUNS | 018577570 |
| Company Name | BIOMET SPINE 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 | 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024337855 [Primary] |
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
[00889024337855]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2019-11-19 |
On-Brand Devices [Nex-Link OCT®]
| 00889024332409 | 2115-4052 |
| 00889024332393 | 2115-4050 |
| 00889024332386 | 2115-4048 |
| 00889024332379 | 2115-4046 |
| 00889024332362 | 2115-4044 |
| 00889024332355 | 2115-4042 |
| 00889024332348 | 2115-4040 |
| 00889024337862 | 7002-01 |
| 00889024337855 | 7001-01 |
Trademark Results [Nex-Link OCT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEX-LINK OCT 77499691 3761655 Live/Registered |
Zimmer Spine, Inc. 2008-06-16 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.