Dexter L6 System
Summary
Distalmotion SA received 510(k) clearance for Dexter L6 System, a SDD device. Cleared on 2026-06-11.
Details
Source
510(k) Clearance
External ID
K260653
Action Date
2026-06-11
Status
Traditional
Category
device
Product Code
SDD
Product Description
Dexter L6 System. Product code: SDD.
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. Distalmotion SA has received 4 total clearances in our database.
Distalmotion SA has 4 FDA actions in our database, including 4 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 Distalmotion SA have FDA actions?
Distalmotion SA has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260653" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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