FDA 510(k)

MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI

K-Number: K111792 · 2012-03-05

Decision Date2012-03-05

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2012-03-05 under 510(k) number K111792. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI?

MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI is a medical device that received FDA 510(k) clearance on 2012-03-05. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K111792.

When did MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI receive FDA 510(k) clearance?

MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI received FDA 510(k) clearance on 2012-03-05, under 510(k) number K111792.

Who is the listed applicant for MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI?

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

What is the FDA product code for MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI?

The FDA product code for MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI is MAX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.