Rebuilder Nerve Guidance Conduit

FDA 510(k) K230794 · Celestray Biotech Company, LLC.,

Substantially Equivalent

510(k) numberK230794

Submission

Device name
Rebuilder Nerve Guidance Conduit
Applicant
Celestray Biotech Company, LLC.,
Bethesda, MD, US
Received
March 22, 2023
Decision date
January 29, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXI – Cuff, Nerve
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5275
Specialty
Neurology
Implant
Yes

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Questions and answers

When was Rebuilder Nerve Guidance Conduit cleared by the FDA?

Rebuilder Nerve Guidance Conduit (K230794) received a 510(k) decision of Substantially Equivalent on January 29, 2024, 313 days after the submission was received.

What is the product code of K230794?

The FDA product code is JXI – Cuff, Nerve, a Class II (moderate risk) device regulated under 21 CFR 882.5275.