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 a medical device manufactured by Subchondral Solutions, Inc.. It received FDA 510(k) clearance on 2020-04-18 under approval 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. It is manufactured by Subchondral Solutions, Inc.. The 510(k) number is K191995.
When was S4 Screw System approved by the FDA?
S4 Screw System received FDA 510(k) clearance on 2020-04-18, under approval number K191995.
What company makes S4 Screw System?
S4 Screw System is manufactured by Subchondral Solutions, Inc..
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.
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Official Source
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