The following data is part of a premarket notification filed by Radiobotics Aps with the FDA for Rbknee.
| Device ID | K203696 |
| 510k Number | K203696 |
| Device Name: | RBknee |
| Classification | System, Image Processing, Radiological |
| Applicant | Radiobotics ApS Strandstrassde 21 4. Th Copenhagen, DK Dk1255 |
| Contact | Martin Christian Axelsen |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700002173614 | K203696 | 000 |