# K013000: Medtronic Invisx Burr Hole Lock, Model 60520

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Dec 5, 2001 after 90 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010361 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010361: Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900, Medtronic PS Medical (2001) Summary page 1.

## Indications for use
The INVISx™ Burr Hole Lock is intended for use in covering burr holes and in refixation of cranial bone flaps following a craniotomy.

Source page: https://510kreport.com/device/K013000
Methodology: https://510kreport.com/methodology