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FDA 510(k)

MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000

K-Number: K091763 · 2009-08-14

ApplicantInstratek, Inc.
Decision Date2009-08-14
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 is the device name listed in this FDA 510(k) record. The listed applicant is Instratek, Inc.. It received FDA 510(k) clearance on 2009-08-14 under 510(k) number K091763. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000?

MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 is a medical device that received FDA 510(k) clearance on 2009-08-14. The listed applicant is Instratek, Inc.. The 510(k) number is K091763.

When did MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 receive FDA 510(k) clearance?

MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 received FDA 510(k) clearance on 2009-08-14, under 510(k) number K091763.

Who is the listed applicant for MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000?

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

What is the FDA product code for MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000?

The FDA product code for MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 is HTN.

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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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