CORE Shoulder System
Summary
LinkBio Corp. received 510(k) clearance for CORE Shoulder System, a QHE device. Cleared on 2025-02-20.
Details
Source
510(k) Clearance
External ID
K241470
Action Date
2025-02-20
Status
Traditional
Category
device
Product Code
QHE
Product Description
CORE Shoulder System. Product code: QHE.
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.
LinkBio Corp. has 51 FDA actions in our database, including 50 recalls and 1 clearance.
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 LinkBio Corp. have FDA actions?
LinkBio Corp. has 51 FDA actions in our database, including 50 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241470" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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