Endoskeleton Interbody Systems
Summary
Medtronic Sofamor Danek USA, Inc. received 510(k) clearance for Endoskeleton Interbody Systems, a MAX device. Cleared on 2025-09-04.
Details
Source
510(k) Clearance
External ID
K251444
Action Date
2025-09-04
Status
Traditional
Category
device
Product Code
MAX
Product Description
Endoskeleton Interbody Systems. Product code: MAX.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 413 device clearances issued this month. Medtronic Sofamor Danek USA, Inc. has received 23 total clearances in our database.
Medtronic Sofamor Danek USA, Inc. has 60 FDA actions in our database, including 37 recalls and 23 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 Medtronic Sofamor Danek USA, Inc. have FDA actions?
Medtronic Sofamor Danek USA, Inc. has 60 FDA actions in our database, including 37 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251444" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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