510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201659Substantially Equivalent

KHEIRON® Spinal Fixation System

S.M.A.I.O, Saint-Priest, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201659 is the FDA 510(k) clearance record for KHEIRON® Spinal Fixation System, a class II device, cleared for S.M.A.I.O on under FDA product code NKB (Thoracolumbosacral Pedicle Screw System). FDA's definition for product code NKB reads: "Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion". FDA records list 11 510(k) clearances for S.M.A.I.O, from to . As of , FDA records show no recalls naming K201659.

Clearance record

Decision date
Received
(109 days to decision)
Product code
NKB Thoracolumbosacral Pedicle Screw System
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
S.m.a.i.o 2, Pl. Berthe Morisot – Parc Technologique, Saint-Priest, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NKB

Trailing 12 months
29 clearances under product code NKB in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code NKB, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20263
March 20260
April 20265
May 20264
June 20262
July 20264
August 20260
September 20265
October 20260