APTUS Clavicle System 2.8
Summary
Medartis AG received 510(k) clearance for APTUS Clavicle System 2.8, a HRS device. Cleared on 2026-06-05.
Details
Source
510(k) Clearance
External ID
K260761
Action Date
2026-06-05
Status
Traditional
Category
device
Product Code
HRS
Product Description
APTUS Clavicle System 2.8. Product code: HRS.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Medartis AG has received 10 total clearances in our database.
Medartis AG has 13 FDA actions in our database, including 3 recalls and 10 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 Medartis AG have FDA actions?
Medartis AG has 13 FDA actions in our database, including 3 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260761" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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