The following data is part of a premarket notification filed by Blue Belt Technologies, Inc. with the FDA for Naviopfs.
| Device ID | K121936 |
| 510k Number | K121936 |
| Device Name: | NAVIOPFS |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | BLUE BELT TECHNOLOGIES, INC. 2828 LIBERTY AVENUE SUITE 100 Pittsburgh, PA 15222 |
| Contact | Richard G Confer |
| Correspondent | Richard G Confer BLUE BELT TECHNOLOGIES, INC. 2828 LIBERTY AVENUE SUITE 100 Pittsburgh, PA 15222 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-02 |
| Decision Date | 2012-11-30 |
| Summary: | summary |