FDA 510(k)

SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115

K-Number: K093820 · 2010-05-19

Decision Date2010-05-19

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 is the device name listed in this FDA 510(k) record. The listed applicant is Memometal Technologies. It received FDA 510(k) clearance on 2010-05-19 under 510(k) number K093820. 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 SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115?

SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 is a medical device that received FDA 510(k) clearance on 2010-05-19. The listed applicant is Memometal Technologies. The 510(k) number is K093820.

When did SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 receive FDA 510(k) clearance?

SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 received FDA 510(k) clearance on 2010-05-19, under 510(k) number K093820.

Who is the listed applicant for SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115?

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

What is the FDA product code for SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115?

The FDA product code for SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 is HWC. This falls under the Cardiovascular category.

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Other records listing Memometal Technologies as applicant

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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.