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FDA 510(k)

UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS

K-Number: K093078 · 2010-06-23

ApplicantBonutti Research, Inc.
Decision Date2010-06-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS 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 2010-06-23 under 510(k) number K093078. 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 ULTRASONIC SYSTEM WITH PLLA ANCHORS?

UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS is a medical device that received FDA 510(k) clearance on 2010-06-23. The listed applicant is Bonutti Research, Inc.. The 510(k) number is K093078.

When did UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS receive FDA 510(k) clearance?

UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS received FDA 510(k) clearance on 2010-06-23, under 510(k) number K093078.

Who is the listed applicant for UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS?

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 ULTRASONIC SYSTEM WITH PLLA ANCHORS?

The FDA product code for UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS 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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