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 |