S4 Screw System
K-Number: K162171 · 2017-09-07
ApplicantSubchondral Solutions
Decision Date2017-09-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
S4 Screw System is a medical device manufactured by Subchondral Solutions. It received FDA 510(k) clearance on 2017-09-07 under approval number K162171. 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 2017-09-07. It is manufactured by Subchondral Solutions. The 510(k) number is K162171.
When was S4 Screw System approved by the FDA?
S4 Screw System received FDA 510(k) clearance on 2017-09-07, under approval number K162171.
What company makes S4 Screw System?
S4 Screw System is manufactured by Subchondral Solutions.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.