The following data is part of a premarket notification filed by Naviswiss Ag with the FDA for Naviplan - Ct Planning Software For Total Hip Replacement.
| Device ID | K211429 |
| 510k Number | K211429 |
| Device Name: | NAVIPLAN - CT Planning Software For Total Hip Replacement |
| Classification | System, Image Processing, Radiological |
| Applicant | Naviswiss AG Stahlrain 2 Brugg, CH 5200 |
| Contact | Jan Stifter |
| Correspondent | Stefano Adami confinis AG Allee 1b Sursee, CH 6210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-07 |
| Decision Date | 2021-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640176970535 | K211429 | 000 |