Arthrosurface Bone Screws
K-Number: K161539 · 2016-06-30
ApplicantArthrosurface, Inc.
Decision Date2016-06-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Arthrosurface Bone Screws is a medical device manufactured by Arthrosurface, Inc.. It received FDA 510(k) clearance on 2016-06-30 under approval number K161539. 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 Arthrosurface Bone Screws?
Arthrosurface Bone Screws is a medical device that received FDA 510(k) clearance on 2016-06-30. It is manufactured by Arthrosurface, Inc.. The 510(k) number is K161539.
When was Arthrosurface Bone Screws approved by the FDA?
Arthrosurface Bone Screws received FDA 510(k) clearance on 2016-06-30, under approval number K161539.
What company makes Arthrosurface Bone Screws?
Arthrosurface Bone Screws is manufactured by Arthrosurface, Inc..
What is the FDA product code for Arthrosurface Bone Screws?
The FDA product code for Arthrosurface Bone Screws 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.