510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010361Substantially Equivalent

Medtronic Ps Medical Invisx Cranial Fixation System, Model 60100-60900

Medtronic PS Medical, Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010361 is the FDA 510(k) clearance record for MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900, a class II device, cleared for Medtronic PS Medical on under FDA product code GXR (Cover, Burr Hole). FDA records list 14 510(k) clearances for Medtronic PS Medical, from to . As of , FDA records show no recalls naming K010361.

Clearance record

Decision date
Received
(90 days to decision)
Product code
GXR Cover, Burr Hole
Regulation
21 CFR 882.5250
Device class
Class II
Review panel
Neurology
Applicant
Medtronic PS Medical 125 Cremona Dr., Goleta CA
510(k) summary
Summary
Third party review
No

Clearances, product code GXR

Trailing 12 months
1 clearance under product code GXR in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GXR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260