BePOD® Foot Screws
K-Number: K163148 · 2017-09-14
ApplicantFournitures Hospitalieres Industrie
Decision Date2017-09-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BePOD® Foot Screws is a medical device manufactured by Fournitures Hospitalieres Industrie. It received FDA 510(k) clearance on 2017-09-14 under approval number K163148. 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 BePOD® Foot Screws?
BePOD® Foot Screws is a medical device that received FDA 510(k) clearance on 2017-09-14. It is manufactured by Fournitures Hospitalieres Industrie. The 510(k) number is K163148.
When was BePOD® Foot Screws approved by the FDA?
BePOD® Foot Screws received FDA 510(k) clearance on 2017-09-14, under approval number K163148.
What company makes BePOD® Foot Screws?
BePOD® Foot Screws is manufactured by Fournitures Hospitalieres Industrie.
What is the FDA product code for BePOD® Foot Screws?
The FDA product code for BePOD® Foot 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.