510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200596Substantially Equivalent

G21 Cement, VADER® Pedicle System

Icotec AG, 9450 Altstaetten (Sg), CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200596 is the FDA 510(k) clearance record for G21 Cement, VADER® Pedicle System, a class II device, cleared for Icotec AG on under FDA product code PML (Bone Cement, Posterior Screw Augmentation). FDA's definition for product code PML reads: "The device is intended to augment the fixation of screws in a posterior spinal system construct". FDA records list 17 510(k) clearances for Icotec AG, from to . As of , FDA records show one recall naming K200596.

Clearance record

Decision date
Received
(221 days to decision)
Product code
PML Bone Cement, Posterior Screw Augmentation
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Icotec AG Industriestrasse 12, 9450 Altstaetten (Sg), CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PML

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