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FDA 510(k)

NanoBone SBX Putty

K-Number: K161351 · 2016-10-26

ApplicantArtoss GmbH
Decision Date2016-10-26
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NanoBone SBX Putty is the device name listed in this FDA 510(k) record. The listed applicant is Artoss GmbH. It received FDA 510(k) clearance on 2016-10-26 under 510(k) number K161351. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NanoBone SBX Putty?

NanoBone SBX Putty is a medical device that received FDA 510(k) clearance on 2016-10-26. The listed applicant is Artoss GmbH. The 510(k) number is K161351.

When did NanoBone SBX Putty receive FDA 510(k) clearance?

NanoBone SBX Putty received FDA 510(k) clearance on 2016-10-26, under 510(k) number K161351.

Who is the listed applicant for NanoBone SBX Putty?

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

What is the FDA product code for NanoBone SBX Putty?

The FDA product code for NanoBone SBX Putty is MQV.

Other records listing Artoss GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190110NanoBone SBX PUTTY, NanoBone QD

Related Devices (Code: MQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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