Affixus® 814550075
GUDID 00887868568251
Biomet Orthopedics, LLC
Orthopaedic bone screw, non-bioabsorbable, sterile| Primary Device ID | 00887868568251 |
| NIH Device Record Key | 58b54edd-77a3-4b29-99c0-7cb3884a3ddc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affixus® |
| Version Model Number | 8145-50-075 |
| Catalog Number | 814550075 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868568251 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100238
FDA Product Code
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-06 |
| Device Publish Date | 2023-05-29 |
On-Brand Devices [Affixus®]
| 00887868568268 | 8145-50-080 |
| 00887868568251 | 8145-50-075 |
| 00887868568244 | 8145-50-070 |
| 00887868568237 | 8145-50-065 |
| 00887868568220 | 8145-50-060 |
| 00887868568213 | 8145-50-058 |
| 00887868568206 | 8145-50-056 |
| 00887868568190 | 8145-50-054 |
| 00887868568183 | 8145-50-052 |
| 00887868568176 | 8145-50-050 |
| 00887868568169 | 8145-50-048 |
| 00887868568152 | 8145-50-046 |
| 00887868568145 | 8145-50-044 |
| 00887868567070 | 8145-50-042 |
| 00887868567063 | 8145-50-040 |
| 00887868567056 | 8145-50-038 |
| 00887868567049 | 8145-50-036 |
| 00887868567032 | 8145-50-034 |
| 00887868567025 | 8145-50-032 |
| 00887868567018 | 8145-50-030 |
| 00887868567001 | 8145-50-028 |
| 00887868566998 | 8145-50-026 |
| 00887868566981 | 8145-50-024 |
| 00887868566974 | 8145-50-022 |
| 00887868566967 | 8145-50-020 |
| 00887868570148 | 2112-01-320 |
| 00887868570025 | 2112-01-209 |
| 00887868570896 | 2112-01-208 |
| 00887868570889 | 2112-01-207 |
Trademark Results [Affixus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFFIXUS 77944955 3912289 Live/Registered |
BIOMET C.V. 2010-02-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.