External Fixation Bone Distractor
K-Number: K251862 · 2025-08-11
ApplicantParagon 28, Inc.
Decision Date2025-08-11
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
External Fixation Bone Distractor is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2025-08-11 under approval number K251862. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the External Fixation Bone Distractor?
External Fixation Bone Distractor is a medical device that received FDA 510(k) clearance on 2025-08-11. It is manufactured by Paragon 28, Inc.. The 510(k) number is K251862.
When was External Fixation Bone Distractor approved by the FDA?
External Fixation Bone Distractor received FDA 510(k) clearance on 2025-08-11, under approval number K251862.
What company makes External Fixation Bone Distractor?
External Fixation Bone Distractor is manufactured by Paragon 28, Inc..
What is the FDA product code for External Fixation Bone Distractor?
The FDA product code for External Fixation Bone Distractor is KTT.
Related Clinical Trials
Other Devices by Paragon 28, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.