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FDA 510(k)

BONOS INJECT

K-Number: K090460 · 2009-04-14

ApplicantAap Biomaterials GmbH
Decision Date2009-04-14
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONOS INJECT is the device name listed in this FDA 510(k) record. The listed applicant is Aap Biomaterials GmbH. It received FDA 510(k) clearance on 2009-04-14 under 510(k) number K090460. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONOS INJECT?

BONOS INJECT is a medical device that received FDA 510(k) clearance on 2009-04-14. The listed applicant is Aap Biomaterials GmbH. The 510(k) number is K090460.

When did BONOS INJECT receive FDA 510(k) clearance?

BONOS INJECT received FDA 510(k) clearance on 2009-04-14, under 510(k) number K090460.

Who is the listed applicant for BONOS INJECT?

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

What is the FDA product code for BONOS INJECT?

The FDA product code for BONOS INJECT is NDN.

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Other records listing Aap Biomaterials GmbH 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.

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