Biomet® Omega 21™ Spinal Fixation System 129130
GUDID 00880304873810
BIOMET SPINE LLC
Uncoated femoral stem prosthesis, one-piece| Primary Device ID | 00880304873810 |
| NIH Device Record Key | 36427138-4297-4468-86a1-334ee04b615a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biomet® Omega 21™ Spinal Fixation System |
| Version Model Number | 129130 |
| Catalog Number | 129130 |
| 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 | true |
| 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 |
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| 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 | 00880304873810 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K942028
FDA Product Code
| JDG | Prosthesis, hip, femoral component, cemented, metal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
[00880304873810]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-01 |
| Device Publish Date | 2020-06-23 |
Devices Manufactured by BIOMET SPINE LLC
| 03662663063234 - Vital Spinal Fixation System | 2024-05-20 S-Rod, 5.5x400mm, Ti Alloy, Avg |
| 03662663063241 - Vital Spinal Fixation System | 2024-05-20 S-Rod, 5.5x510mm, Ti Alloy, Avg |
| 03662663063258 - Vital Spinal Fixation System | 2024-05-20 S-Rod, 5.5x400mm, CoCr, Avg |
| 03662663063265 - Vital Spinal Fixation System | 2024-05-20 S-Rod, 5.5x510mm, CoCr, Avg |
| 03662663063272 - Vital Spinal Fixation System | 2024-05-20 S-Rod, 6.0x400mm, Ti Alloy, Avg |
| 03662663063289 - Vital Spinal Fixation System | 2024-05-20 S-Rod, 6.0x510mm, Ti Alloy, Avg |
| 03662663063296 - Vital Spinal Fixation System | 2024-05-20 S-Rod, 6.0x400mm, CoCr, Avg |
| 03662663063302 - Vital Spinal Fixation System | 2024-05-20 S-Rod, 6.0x510mm, CoCr, Avg |
Trademark Results [Biomet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOMET 79083976 not registered Dead/Abandoned |
VEOLIA WATER TECHNOLOGIES ITALIA S.p.A. 2010-03-23 |
 BIOMET 78703978 3176481 Live/Registered |
ZIMMER, INC. 2005-08-31 |
 BIOMET 78498921 3235830 Dead/Cancelled |
ARKEMA, INC. 2004-10-13 |
 BIOMET 75282520 2301253 Live/Registered |
ZIMMER, INC. 1997-04-10 |
 BIOMET 74722414 not registered Dead/Abandoned |
NOREL, S.A. 1995-08-29 |
 BIOMET 73585352 1411822 Live/Registered |
BIOMET, INC. 1986-02-28 |
 BIOMET 73165517 1153792 Live/Registered |
BIOMET, INC. 1978-04-07 |
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