510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261830Substantially Equivalent

FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)

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

K261830 is the FDA 510(k) clearance record for FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog), a class II device, cleared for Ortler Global Tibbi Gerecler Anonim Sirketi on under FDA product code HRS (Plate, Fixation, Bone). As of , FDA records show no recalls naming K261830.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
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 HRS

Trailing 12 months
57 clearances under product code HRS in the twelve months to October 2026, March 2026 the highest month at 13.
Show the numbers
Monthly 510(k) clearances under FDA product code HRS, trailing twelve months
MonthClearances
November 20255
December 20255
January 20264
February 20265
March 202613
April 20266
May 20262
June 20265
July 20265
August 20263
September 20264
October 20260