Polaris™ 4.75 Spinal System 14-583245
GUDID 00880304935853
BIOMET SPINE LLC
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00880304935853 |
| NIH Device Record Key | 968e56df-e1e0-4287-bc1f-c11b7944cef7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polaris™ 4.75 Spinal System |
| Version Model Number | 14-583245 |
| Catalog Number | 14-583245 |
| 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 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 | 00880304935853 [Primary] |
FDA Product Code
| MNI | Orthosis, spinal pedicle fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
[00880304935853]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-03 |
| Device Publish Date | 2020-06-25 |
On-Brand Devices [Polaris™ 4.75 Spinal System]
Trademark Results [Polaris]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLARIS 98886838 not registered Live/Pending |
NorthStar Digital Solutions Inc. 2024-12-05 |
 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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.