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FDA 510(k)

A-Oss

K-Number: K151542 · 2016-08-03

ApplicantHiossen, Inc.
Decision Date2016-08-03
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-Oss is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2016-08-03 under 510(k) number K151542. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-Oss?

A-Oss is a medical device that received FDA 510(k) clearance on 2016-08-03. The listed applicant is Hiossen, Inc.. The 510(k) number is K151542.

When did A-Oss receive FDA 510(k) clearance?

A-Oss received FDA 510(k) clearance on 2016-08-03, under 510(k) number K151542.

Who is the listed applicant for A-Oss?

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

What is the FDA product code for A-Oss?

The FDA product code for A-Oss is NPM.

Other records listing Hiossen, Inc. 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.

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Related Devices (Code: NPM)

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.

K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGK251613SwissGraft XGeistlich Pharma AGK242510Geistlich Bio-Flow®Geistlich Pharma AGK240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLCK230305THE Graft CollagenPurgo Biologics, Inc.

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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