FDA 510(k)

Arthrex Compression FT Pins

K-Number: K220839 · 2022-09-19

Decision Date2022-09-19

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrex Compression FT Pins is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2022-09-19 under 510(k) number K220839. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Compression FT Pins?

Arthrex Compression FT Pins is a medical device that received FDA 510(k) clearance on 2022-09-19. The listed applicant is Arthrex, Inc.. The 510(k) number is K220839.

When did Arthrex Compression FT Pins receive FDA 510(k) clearance?

Arthrex Compression FT Pins received FDA 510(k) clearance on 2022-09-19, under 510(k) number K220839.

Who is the listed applicant for Arthrex Compression FT Pins?

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 Compression FT Pins?

The FDA product code for Arthrex Compression FT Pins is HWC. This falls under the Cardiovascular category.

Other records listing Arthrex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262357Arthrex Bioabsorbable PushLock Suture Anchors K260624Arthrex Radial Head Replacement System K260018Arthrex FiberButton K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System K253931Arthrex Bioabsorbable PushLock Suture Anchors K254215Arthrex Beaming System

View all 173 devices →

Related Devices (Code: HWC)

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLC K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps Ortho K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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.