X-Fix Dynamic External Distractor

FDA 510(k) K122415 · Arex USA, LLC

Substantially Equivalent

510(k) numberK122415

Submission

Device name
X-Fix Dynamic External Distractor
Applicant
Arex USA, LLC
Edgewater, FL, US
Received
August 8, 2012
Decision date
March 15, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HTY – Pin, Fixation, Smooth
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was X-Fix Dynamic External Distractor cleared by the FDA?

X-Fix Dynamic External Distractor (K122415) received a 510(k) decision of Substantially Equivalent on March 15, 2013, 219 days after the submission was received.

What is the product code of K122415?

The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.