Entasis 3D Dual-Lead Sacroiliac Implant System
Summary
Corelink, LLC received 510(k) clearance for Entasis 3D Dual-Lead Sacroiliac Implant System, a OUR device. Cleared on 2023-03-21.
Details
Source
510(k) Clearance
External ID
K223708
Action Date
2023-03-21
Status
Traditional
Category
device
Product Code
OUR
Product Description
Entasis 3D Dual-Lead Sacroiliac Implant System. Product code: OUR.
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. Corelink, LLC has received 11 total clearances in our database.
Corelink, LLC has 12 FDA actions in our database, including 1 recall and 11 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 Corelink, LLC have FDA actions?
Corelink, LLC has 12 FDA actions in our database, including 1 recall and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223708" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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