SMV Scientific Schanz Screws
K-Number: K160603 · 2016-03-28
ApplicantSmv Scientific
Decision Date2016-03-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SMV Scientific Schanz Screws is a medical device manufactured by Smv Scientific. It received FDA 510(k) clearance on 2016-03-28 under approval number K160603. 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 SMV Scientific Schanz Screws?
SMV Scientific Schanz Screws is a medical device that received FDA 510(k) clearance on 2016-03-28. It is manufactured by Smv Scientific. The 510(k) number is K160603.
When was SMV Scientific Schanz Screws approved by the FDA?
SMV Scientific Schanz Screws received FDA 510(k) clearance on 2016-03-28, under approval number K160603.
What company makes SMV Scientific Schanz Screws?
SMV Scientific Schanz Screws is manufactured by Smv Scientific.
What is the FDA product code for SMV Scientific Schanz Screws?
The FDA product code for SMV Scientific Schanz 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.