| Primary Device ID | 00810021866307 |
| NIH Device Record Key | b142693b-22e9-4c70-9d69-91dcb2b16b69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avenger Radial Head, +4 Stems |
| Version Model Number | M70 SC255 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021866307 [Primary] |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-07 |
| Device Publish Date | 2022-01-28 |
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| 00810021866383 | Avenger Radial Head Stem Implant, Size Ø8.5 x 25 mm, +4mm |
| 00810021866376 | Avenger Radial Head Stem Implant, Size Ø7.5 x 25 mm, +4mm |
| 00810021866369 | Avenger Radial Head Stem Implant, Size Ø6.5 x 24 mm, +4mm |
| 00810021866352 | Avenger Radial Head Stem Implant, Size Ø5.5 x 24 mm, +4mm |
| 00810021866345 | Avenger Radial Head Stem Implant, Size Ø9.5 x 17 mm, +4mm |
| 00810021866338 | Avenger Radial Head Stem Implant, Size Ø8.5 x 17 mm, +4mm |
| 00810021866321 | Avenger Radial Head Stem Implant, Size Ø7.5 x 17 mm, +4mm |
| 00810021866314 | Avenger Radial Head Stem Implant, Size Ø6.5 x 16 mm, +4mm |
| 00810021866307 | Avenger Radial Head Stem Implant, Size Ø5.5 x 16 mm, +4mm |