The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Galileo Cas/nav Tkr System.
| Device ID | K020298 |
| 510k Number | K020298 |
| Device Name: | GALILEO CAS/NAV TKR SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | PLUS ORTHOPEDICS 6055 LUSK BLVD. San Diego, CA 92121 -2700 |
| Contact | Hartmut Loch |
| Correspondent | Hartmut Loch PLUS ORTHOPEDICS 6055 LUSK BLVD. San Diego, CA 92121 -2700 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-28 |
| Decision Date | 2002-05-20 |
| Summary: | summary |