Avenger Radial Head M07 S0001
GUDID 00817906028959
Avenger Radial Head System, Trials, Sterile Kit
IN2BONES USA, LLC
General internal orthopaedic fixation system implantation kit| Primary Device ID | 00817906028959 |
| NIH Device Record Key | 682fe647-7b19-48a4-8cf3-177c2b88a040 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avenger Radial Head |
| Version Model Number | M07 S0001 |
| Catalog Number | M07 S0001 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817906028959 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192754
FDA Product Code
| LXH | Orthopedic manual surgical instrument |
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 | 2024-12-13 |
| Device Publish Date | 2024-12-05 |
On-Brand Devices [Avenger Radial Head]
| 00817906028980 | AVENGER RADIAL HEAD INSTRUMENT TRAY |
| 00817906028973 | Avenger Radial Head System Reamers 7.5 through 9.5, Sterile |
| 00817906028966 | Avenger Radial Head System Awl, 5.6 and 6.5, Planer, Sterile |
| 00817906028959 | Avenger Radial Head System, Trials, Sterile Kit |
| 00810021866406 | Avenger Radial Head Trials, +4mm Stems, Sterile Kit |
Trademark Results [Avenger Radial Head]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVENGER RADIAL HEAD 88386420 not registered Live/Pending |
In2Bones USA, LLC 2019-04-15 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.