510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K022222Substantially Equivalent

Lamitrode S-Series (S4 and S8) Leads

Advanced Neuromodulation System,Inc, Plano TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K022222 is the FDA 510(k) clearance record for LAMITRODE S-SERIES (S4 AND S8) LEADS, a class II device, cleared for Advanced Neuromodulation System,Inc on under FDA product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). FDA records list one 510(k) clearance for Advanced Neuromodulation System,Inc. As of , FDA records show no recalls naming K022222.

Clearance record

Decision date
Received
(30 days to decision)
Product code
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation
21 CFR 882.5880
Device class
Class II
Review panel
Neurology
Applicant
Advanced Neuromodulation System,Inc 6501 Windcrest Dr.,Sute 100, Plano TX
510(k) summary
Statement
Third party review
No

Clearances, product code GZB

Trailing 12 months

FDA records hold no clearances under product code GZB in the trailing twelve months.

FDA records show no clearances under product code GZB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260