The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Medtronic Invisx Burr Hole Lock, Model 60520.
| Device ID | K013000 |
| 510k Number | K013000 |
| Device Name: | MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR., Goleta, CA 93117 |
| Contact | Janet Mcauley |
| Correspondent | Janet Mcauley MEDTRONIC NEUROSURGERY 125 CREMONA DR., Goleta, CA 93117 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-06 |
| Decision Date | 2001-12-05 |
| Summary: | summary |