FDA 510(k)

Arthrex Vortex Threaded Bone Marrow Recovery Needle

K-Number: K213213 · 2021-11-19

Decision Date2021-11-19

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Arthrex Vortex Threaded Bone Marrow Recovery Needle is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K213213. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Vortex Threaded Bone Marrow Recovery Needle?

Arthrex Vortex Threaded Bone Marrow Recovery Needle is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Arthrex, Inc.. The 510(k) number is K213213.

When did Arthrex Vortex Threaded Bone Marrow Recovery Needle receive FDA 510(k) clearance?

Arthrex Vortex Threaded Bone Marrow Recovery Needle received FDA 510(k) clearance on 2021-11-19, under 510(k) number K213213.

Who is the listed applicant for Arthrex Vortex Threaded Bone Marrow Recovery Needle?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arthrex Vortex Threaded Bone Marrow Recovery Needle?

The FDA product code for Arthrex Vortex Threaded Bone Marrow Recovery Needle is KNW.

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NCT05753891Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)TERMINATED NCT05258357Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure StudyCOMPLETED

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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.