The following data is part of a premarket notification filed by Ulrich Medical Usa with the FDA for Navigation Module Of The Momentum System.
| Device ID | K200845 |
| 510k Number | K200845 |
| Device Name: | Navigation Module Of The Momentum System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | ulrich Medical USA 18221 Edison Avenue Chesterfield, MO 63005 |
| Contact | Hans Stover |
| Correspondent | Hans Stover ulrich Medical USA 18221 Edison Avenue Chesterfield, MO 63005 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-31 |
| Decision Date | 2020-09-10 |