510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K262091Substantially Equivalent

FRAXION Spinal Fixation System

Ortler Global Tibbi Gerecler Anonim Sirketi, Ankara, TR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(87 days to decision)
Product code
NKB Thoracolumbosacral Pedicle Screw System
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Ortler Global Tibbi Gerecler Anonim Sirketi Ivedikkoy Mah., 1492 Cadde, 17 B, 43, Yenimahalle, Ankara, TR
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