| Primary Device ID | 00848665035995 |
| NIH Device Record Key | cf75218e-27b8-4145-83c9-19412b4abd9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VARIABLE ANGLE LOCKING SCREW, 3.5mm x 100mm |
| Version Model Number | 8088-100 |
| Company DUNS | 117858154 |
| Company Name | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
| 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 | true |
| 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 | 3105339966 |
| regaffairs@aosortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848665035995 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00848665035995]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-02-19 |
| Device Publish Date | 2020-05-27 |
| 00848665028980 - SEMI-TUBULAR PLATE, 13-HOLE | 2024-11-13 |
| 00848665029000 - SEMI-TUBULAR PLATE, 15-HOLE | 2024-11-13 |
| 00848665029017 - SEMI-TUBULAR PLATE, 17-HOLE | 2024-11-13 |
| 00848665029024 - SEMI-TUBULAR PLATE, 19-HOLE | 2024-11-13 |
| 00848665029031 - SEMI-TUBULAR PLATE, 21-HOLE | 2024-11-13 |
| 00848665029048 - STRAIGHT PLATE, 13-HOLE | 2024-11-13 |
| 00848665029055 - STRAIGHT PLATE, 15-HOLE | 2024-11-13 |
| 00848665029062 - STRAIGHT PLATE, 17-HOLE | 2024-11-13 |