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FDA 510(k)

S4 Screw System

K-Number: K191995 · 2020-04-18

ApplicantSubchondral Solutions, Inc.
Decision Date2020-04-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

S4 Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Subchondral Solutions, Inc.. It received FDA 510(k) clearance on 2020-04-18 under 510(k) number K191995. 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 S4 Screw System?

S4 Screw System is a medical device that received FDA 510(k) clearance on 2020-04-18. The listed applicant is Subchondral Solutions, Inc.. The 510(k) number is K191995.

When did S4 Screw System receive FDA 510(k) clearance?

S4 Screw System received FDA 510(k) clearance on 2020-04-18, under 510(k) number K191995.

Who is the listed applicant for S4 Screw System?

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

What is the FDA product code for S4 Screw System?

The FDA product code for S4 Screw System is HWC. This falls under the Cardiovascular category.

Other records listing Subchondral Solutions, 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.

K220901S-Core Implant SystemK162171S4 Screw System™

Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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