QuikFix External Fixator: Knee-Spanning Pack
Summary
Stabiliz Orthopaedics, Inc. received 510(k) clearance for QuikFix External Fixator: Knee-Spanning Pack, a KTT device. Cleared on 2026-03-23.
Details
Source
510(k) Clearance
External ID
K260112
Action Date
2026-03-23
Status
Traditional
Category
device
Product Code
KTT
Product Description
QuikFix External Fixator: Knee-Spanning Pack. Product code: KTT.
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. Stabiliz Orthopaedics, Inc. has received 2 total clearances in our database.
Stabiliz Orthopaedics, Inc. 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 Stabiliz Orthopaedics, Inc. have FDA actions?
Stabiliz Orthopaedics, Inc. 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 "K260112" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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