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FDA 510(k)

BIOPRO GO-EZ SCREW

K-Number: K081149 · 2008-08-05

ApplicantBiopro, Inc.
Decision Date2008-08-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOPRO GO-EZ SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 2008-08-05 under 510(k) number K081149. 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 BIOPRO GO-EZ SCREW?

BIOPRO GO-EZ SCREW is a medical device that received FDA 510(k) clearance on 2008-08-05. The listed applicant is Biopro, Inc.. The 510(k) number is K081149.

When did BIOPRO GO-EZ SCREW receive FDA 510(k) clearance?

BIOPRO GO-EZ SCREW received FDA 510(k) clearance on 2008-08-05, under 510(k) number K081149.

Who is the listed applicant for BIOPRO GO-EZ SCREW?

The FDA 510(k) record lists Biopro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPRO GO-EZ SCREW?

The FDA product code for BIOPRO GO-EZ SCREW 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.

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