| Primary Device ID | 00880304836907 |
| NIH Device Record Key | 42b351b8-b927-43f7-a3a5-15f0269c656f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spinal System |
| Version Model Number | 131M1214 |
| Catalog Number | 131M1214 |
| Company DUNS | 018577570 |
| Company Name | BIOMET SPINE LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com | |
| Phone | +1(800)447-3625 |
| USBROCustomerService@zimmerbiomet.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304836907 [Primary] |
| GFI | OSTEOTOME, MANUAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
[00880304836907]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-26 |
| Device Publish Date | 2018-09-25 |