FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Fournitures Hospitalieres Industrie. It received FDA 510(k) clearance on 2017-09-14 under 510(k) 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. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K163148.

When did BePOD® Foot Screws receive FDA 510(k) clearance?

BePOD® Foot Screws received FDA 510(k) clearance on 2017-09-14, under 510(k) number K163148.

Who is the listed applicant for BePOD® Foot Screws?

The FDA 510(k) record lists Fournitures Hospitalieres Industrie as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Fournitures Hospitalieres Industrie as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171789ARROW Reverse Porous Glenoid K163710BePOD® EZ Weil Screws K162068ARROW Anatomical Porous glenoid K170040BePOD Cannulated Arthrodesis Screws

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.