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FDA 510(k)

UNITY BETA PLLA SYSTEM

K-Number: K090175 · 2009-09-10

ApplicantBonutti Research, Inc.
Decision Date2009-09-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITY BETA PLLA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bonutti Research, Inc.. It received FDA 510(k) clearance on 2009-09-10 under 510(k) number K090175. 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 UNITY BETA PLLA SYSTEM?

UNITY BETA PLLA SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-10. The listed applicant is Bonutti Research, Inc.. The 510(k) number is K090175.

When did UNITY BETA PLLA SYSTEM receive FDA 510(k) clearance?

UNITY BETA PLLA SYSTEM received FDA 510(k) clearance on 2009-09-10, under 510(k) number K090175.

Who is the listed applicant for UNITY BETA PLLA SYSTEM?

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

What is the FDA product code for UNITY BETA PLLA SYSTEM?

The FDA product code for UNITY BETA PLLA SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Bonutti Research, Inc. 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.

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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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