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FDA 510(k)

Geistlich Bio-Oss®

K-Number: K240661 · 2024-07-12

ApplicantGeistlich Pharma AG
Decision Date2024-07-12
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Geistlich Bio-Oss® is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2024-07-12 under 510(k) number K240661. 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 Geistlich Bio-Oss®?

Geistlich Bio-Oss® is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Geistlich Pharma AG. The 510(k) number is K240661.

When did Geistlich Bio-Oss® receive FDA 510(k) clearance?

Geistlich Bio-Oss® received FDA 510(k) clearance on 2024-07-12, under 510(k) number K240661.

Who is the listed applicant for Geistlich Bio-Oss®?

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

What is the FDA product code for Geistlich Bio-Oss®?

The FDA product code for Geistlich Bio-Oss® is NPM.

Other records listing Geistlich Pharma AG 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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