The Response Ortho Smart Fixator - Hexapod System
Summary
Response Ortho Solutions, LLC received 510(k) clearance for The Response Ortho Smart Fixator - Hexapod System, a KTT device. Cleared on 2025-11-20.
Details
Source
510(k) Clearance
External ID
K252625
Action Date
2025-11-20
Status
Traditional
Category
device
Product Code
KTT
Product Description
The Response Ortho Smart Fixator - Hexapod System. Product code: KTT.
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. Response Ortho Solutions, LLC has received 2 total clearances in our database.
Response Ortho Solutions, LLC has 2 FDA actions in our database, including 2 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 Response Ortho Solutions, LLC have FDA actions?
Response Ortho Solutions, LLC has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252625" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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