Cannulated Screws Neoortho
K-Number: K162874 · 2017-06-27
ApplicantNeoortho Produtos Ortopedicos S/A
Decision Date2017-06-27
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Cannulated Screws Neoortho is a medical device manufactured by Neoortho Produtos Ortopedicos S/A. It received FDA 510(k) clearance on 2017-06-27 under approval number K162874. 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 Cannulated Screws Neoortho?
Cannulated Screws Neoortho is a medical device that received FDA 510(k) clearance on 2017-06-27. It is manufactured by Neoortho Produtos Ortopedicos S/A. The 510(k) number is K162874.
When was Cannulated Screws Neoortho approved by the FDA?
Cannulated Screws Neoortho received FDA 510(k) clearance on 2017-06-27, under approval number K162874.
What company makes Cannulated Screws Neoortho?
Cannulated Screws Neoortho is manufactured by Neoortho Produtos Ortopedicos S/A.
What is the FDA product code for Cannulated Screws Neoortho?
The FDA product code for Cannulated Screws Neoortho 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.