MUTARS® femoral stem cemented 160 mm and 200 mm
Summary
Implantcast GmbH received 510(k) clearance for MUTARS® femoral stem cemented 160 mm and 200 mm, a LZO device. Cleared on 2024-10-24.
Details
Source
510(k) Clearance
External ID
K240391
Action Date
2024-10-24
Status
Traditional
Category
device
Product Code
LZO
Product Description
MUTARS® femoral stem cemented 160 mm and 200 mm. Product code: LZO.
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. Implantcast GmbH has received 10 total clearances in our database.
Implantcast GmbH has 11 FDA actions in our database, including 1 recall and 10 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 Implantcast GmbH have FDA actions?
Implantcast GmbH has 11 FDA actions in our database, including 1 recall and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240391" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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