mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
Summary
MED-EL Elektromedizinische Geräte GmbH received 510(k) clearance for mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit, a ETA device. Cleared on 2025-01-17.
Details
Source
510(k) Clearance
External ID
K241269
Action Date
2025-01-17
Status
Traditional
Category
device
Product Code
ETA
Product Description
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit. Product code: ETA.
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. MED-EL Elektromedizinische Geräte GmbH has received 6 total clearances in our database.
MED-EL Elektromedizinische Geräte GmbH has 6 FDA actions in our database, including 6 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 MED-EL Elektromedizinische Geräte GmbH have FDA actions?
MED-EL Elektromedizinische Geräte GmbH has 6 FDA actions in our database, including 0 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241269" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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