| Primary Device ID | 00880304818903 |
| NIH Device Record Key | bf5c53a8-530c-4c06-89db-9b53093069e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POLARIS 5.5 SPINAL SYSTEM |
| Version Model Number | 20005539R |
| Catalog Number | 20005539R |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304818903 [Primary] |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
[00880304818903]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-03-24 |