FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate Sys
Summary
Ortler Global Tibbi Gerecler Anonim Sirketi received 510(k) clearance 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 HRS device. Cleared on 2026-08-28.
Details
Source
510(k) Clearance
External ID
K261830
Action Date
2026-08-28
Status
Traditional
Category
device
Product Code
HRS
Product Description
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). Product code: HRS.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 445 device clearances issued this month. Ortler Global Tibbi Gerecler Anonim Sirketi has received 2 total clearances in our database.
Ortler Global Tibbi Gerecler Anonim Sirketi has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Ortler Global Tibbi Gerecler Anonim Sirketi have FDA actions?
Ortler Global Tibbi Gerecler Anonim Sirketi has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K261830" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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