The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Quadcut.
| Device ID | K130608 |
| 510k Number | K130608 |
| Device Name: | QUADCUT |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville, CO 80027 |
| Contact | Sharon Mcdermott |
| Correspondent | Sharon Mcdermott MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville, CO 80027 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-07 |
| Decision Date | 2013-08-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QUADCUT 85067363 3942261 Live/Registered |
Medtronic Xomed, Inc. 2010-06-21 |