Polaris™ 6.35 Spinal System 14-513140R
GUDID 00880304965126
BIOMET SPINE LLC
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00880304965126 |
| NIH Device Record Key | 771d8063-6afc-4c9b-a834-ca961b4185c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polaris™ 6.35 Spinal System |
| Version Model Number | 14-513140R |
| Catalog Number | 14-513140R |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304965126 [Primary] |
FDA Product Code
| MNH | Orthosis, spondylolisthesis spinal fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
[00880304965126]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-02 |
| Device Publish Date | 2020-06-24 |
On-Brand Devices [Polaris™ 6.35 Spinal System]
Trademark Results [Polaris]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLARIS 98863002 not registered Live/Pending |
MATEREAL INC. 2024-11-20 |
 POLARIS 98837447 not registered Live/Pending |
Wpromote LLC 2024-11-05 |
 POLARIS 98689320 not registered Live/Pending |
Polaris Industries Inc. 2024-08-08 |
 POLARIS 98650985 not registered Live/Pending |
Polaris Industries Inc. 2024-07-16 |
 POLARIS 98602420 not registered Live/Pending |
Shopify Inc. 2024-06-14 |
 POLARIS 98542974 not registered Live/Pending |
Membrane Technology and Research, Inc. 2024-05-09 |
 POLARIS 98457168 not registered Live/Pending |
Tidal Flight, Inc. 2024-03-19 |
 POLARIS 98432314 not registered Live/Pending |
Nzytech, Lda 2024-03-04 |
 POLARIS 98317305 not registered Live/Pending |
Sky Bacon Technology Holdings, LLC 2023-12-15 |
 POLARIS 98242561 not registered Live/Pending |
Ballbaron.com LLC 2023-10-26 |
 POLARIS 98232012 not registered Live/Pending |
CEREVASC, INC. 2023-10-19 |
 POLARIS 98182468 not registered Live/Pending |
Airtron, Inc. 2023-09-15 |
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