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FDA 510(k)

BIODRIVE CANNULATED SCREW SYSTEM

K-Number: K082874 · 2009-02-05

ApplicantBiomet Trauma
Decision Date2009-02-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIODRIVE CANNULATED SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Trauma. It received FDA 510(k) clearance on 2009-02-05 under 510(k) number K082874. 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 BIODRIVE CANNULATED SCREW SYSTEM?

BIODRIVE CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-05. The listed applicant is Biomet Trauma. The 510(k) number is K082874.

When did BIODRIVE CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

BIODRIVE CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 2009-02-05, under 510(k) number K082874.

Who is the listed applicant for BIODRIVE CANNULATED SCREW SYSTEM?

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

What is the FDA product code for BIODRIVE CANNULATED SCREW SYSTEM?

The FDA product code for BIODRIVE CANNULATED SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Biomet Trauma as applicant

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Related Devices (Code: HWC)

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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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