The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter.
| Device ID | K131425 |
| 510k Number | K131425 |
| Device Name: | NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Regina Holmes |
| Correspondent | Regina Holmes MEDTRONIC NAVIGATION, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-17 |
| Decision Date | 2013-08-14 |
| Summary: | summary |