ActivOrtho Nitinol Compression Screw System
K-Number: K181610 · 2019-03-12
ApplicantActivortho, Inc.
Decision Date2019-03-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ActivOrtho Nitinol Compression Screw System is a medical device manufactured by Activortho, Inc.. It received FDA 510(k) clearance on 2019-03-12 under approval number K181610. 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 ActivOrtho Nitinol Compression Screw System?
ActivOrtho Nitinol Compression Screw System is a medical device that received FDA 510(k) clearance on 2019-03-12. It is manufactured by Activortho, Inc.. The 510(k) number is K181610.
When was ActivOrtho Nitinol Compression Screw System approved by the FDA?
ActivOrtho Nitinol Compression Screw System received FDA 510(k) clearance on 2019-03-12, under approval number K181610.
What company makes ActivOrtho Nitinol Compression Screw System?
ActivOrtho Nitinol Compression Screw System is manufactured by Activortho, Inc..
What is the FDA product code for ActivOrtho Nitinol Compression Screw System?
The FDA product code for ActivOrtho Nitinol 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.