INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
Summary
Depuy Ireland UC received 510(k) clearance for INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid, a MBF device. Cleared on 2023-11-13.
Details
Source
510(k) Clearance
External ID
K230831
Action Date
2023-11-13
Status
Traditional
Category
device
Product Code
MBF
Product Description
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid. Product code: MBF.
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. Depuy Ireland UC has received 35 total clearances in our database.
Depuy Ireland UC has 36 FDA actions in our database, including 1 recall and 35 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 Depuy Ireland UC have FDA actions?
Depuy Ireland UC has 36 FDA actions in our database, including 1 recall and 35 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230831" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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