The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Avenger Radial Head System.
| Device ID | K212872 |
| 510k Number | K212872 |
| Device Name: | Avenger Radial Head System |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis, TN 38119 |
| Contact | Christine Scifert |
| Correspondent | Christine Scifert In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis, TN 38119 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-09 |
| Decision Date | 2021-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810021866390 | K212872 | 000 |
| 00810021866314 | K212872 | 000 |
| 00810021866321 | K212872 | 000 |
| 00810021866338 | K212872 | 000 |
| 00810021866345 | K212872 | 000 |
| 00810021866352 | K212872 | 000 |
| 00810021866369 | K212872 | 000 |
| 00810021866376 | K212872 | 000 |
| 00810021866383 | K212872 | 000 |
| 00810021866307 | K212872 | 000 |