External Fixation Bone Distractor
Summary
Paragon 28, Inc. received 510(k) clearance for External Fixation Bone Distractor, a KTT device. Cleared on 2025-08-11.
Details
Source
510(k) Clearance
External ID
K251862
Action Date
2025-08-11
Status
Traditional
Category
device
Product Code
KTT
Product Description
External Fixation Bone Distractor. 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. Paragon 28, Inc. has received 30 total clearances in our database.
Paragon 28, Inc. has 38 FDA actions in our database, including 8 recalls and 30 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 Paragon 28, Inc. have FDA actions?
Paragon 28, Inc. has 38 FDA actions in our database, including 8 recalls and 30 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251862" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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