SIGN Compression Screw System
K-Number: K153759 · 2016-02-25
ApplicantSign Fracture Care International
Decision Date2016-02-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SIGN Compression Screw System is a medical device manufactured by Sign Fracture Care International. It received FDA 510(k) clearance on 2016-02-25 under approval number K153759. 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 SIGN Compression Screw System?
SIGN Compression Screw System is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by Sign Fracture Care International. The 510(k) number is K153759.
When was SIGN Compression Screw System approved by the FDA?
SIGN Compression Screw System received FDA 510(k) clearance on 2016-02-25, under approval number K153759.
What company makes SIGN Compression Screw System?
SIGN Compression Screw System is manufactured by Sign Fracture Care International.
What is the FDA product code for SIGN Compression Screw System?
The FDA product code for SIGN Compression 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.