SECURE Screw
K-Number: K191771 · 2019-10-16
ApplicantA.M. Surgical, Inc.
Decision Date2019-10-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SECURE Screw is a medical device manufactured by A.M. Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-16 under approval number K191771. 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 SECURE Screw?
SECURE Screw is a medical device that received FDA 510(k) clearance on 2019-10-16. It is manufactured by A.M. Surgical, Inc.. The 510(k) number is K191771.
When was SECURE Screw approved by the FDA?
SECURE Screw received FDA 510(k) clearance on 2019-10-16, under approval number K191771.
What company makes SECURE Screw?
SECURE Screw is manufactured by A.M. Surgical, Inc..
What is the FDA product code for SECURE Screw?
The FDA product code for SECURE Screw is HWC. This falls under the Cardiovascular category.
Other Devices by A.M. Surgical, Inc.
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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.