NO PROFILE 905418
GUDID 00880304420793
Biomet Sports Medicine, LLC
Orthopaedic fixation plate, bioabsorbable| Primary Device ID | 00880304420793 |
| NIH Device Record Key | 1ae6bff2-5ffc-44bb-b5ab-f5536b0d8f3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NO PROFILE |
| Version Model Number | 905418 |
| Catalog Number | 905418 |
| Company DUNS | 627100159 |
| Company Name | Biomet Sports Medicine, 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 | 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 |
| 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 | 00880304420793 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K012469
FDA Product Code
| HTN | WASHER, BOLT NUT |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [NO PROFILE]
| 00880304420793 | 905418 |
| 00880304420786 | 905407 |
| 00880304420779 | 905406 |
| 00880304420762 | 905405 |
| 00880304420755 | 905404 |
| 00880304420748 | 905403 |
| 00880304420731 | 905402 |
| 00880304420724 | 905401 |
Trademark Results [NO PROFILE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NO PROFILE 76696863 3868807 Live/Registered |
CENTINEL SPINE, LLC 2009-04-14 |
 NO PROFILE 76637949 3154654 Live/Registered |
WAY MARINE DESIGN, INC. 2005-05-05 |
 NO PROFILE 75354843 not registered Dead/Abandoned |
Valois of America, Inc. 1997-09-11 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.