The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Avenger Radial Head System.
| Device ID | K192754 |
| 510k Number | K192754 |
| 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 | 2019-09-30 |
| Decision Date | 2020-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817906028942 | K192754 | 000 |
| 00817906028829 | K192754 | 000 |
| 00817906028812 | K192754 | 000 |
| 00817906028805 | K192754 | 000 |
| 00817906028799 | K192754 | 000 |
| 00817906028782 | K192754 | 000 |
| 00817906028775 | K192754 | 000 |
| 00817906028768 | K192754 | 000 |
| 00817906028751 | K192754 | 000 |
| 00817906028744 | K192754 | 000 |
| 00817906028836 | K192754 | 000 |
| 00817906028843 | K192754 | 000 |
| 00817906028935 | K192754 | 000 |
| 00817906028928 | K192754 | 000 |
| 00817906028911 | K192754 | 000 |
| 00817906028904 | K192754 | 000 |
| 00817906028898 | K192754 | 000 |
| 00817906028881 | K192754 | 000 |
| 00817906028874 | K192754 | 000 |
| 00817906028867 | K192754 | 000 |
| 00817906028850 | K192754 | 000 |
| 00817906028737 | K192754 | 000 |