Y-Knotless Flex Anchors
Summary
Conmed Corporation received 510(k) clearance for Y-Knotless Flex Anchors, a MBI device. Cleared on 2026-01-29.
Details
Source
510(k) Clearance
External ID
K253763
Action Date
2026-01-29
Status
Special
Category
device
Product Code
MBI
Product Description
Y-Knotless Flex Anchors. Product code: MBI.
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 413 device clearances issued this month. Conmed Corporation has received 17 total clearances in our database.
Conmed Corporation has 29 FDA actions in our database, including 12 recalls and 17 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 Conmed Corporation have FDA actions?
Conmed Corporation has 29 FDA actions in our database, including 12 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253763" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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