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FDA 510(k)

Xenograft Bovine Bone Particulate

K-Number: K240133 · 2024-08-16

ApplicantCollagen Solutions, LLC
Decision Date2024-08-16
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Xenograft Bovine Bone Particulate is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Solutions, LLC. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K240133. 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 Xenograft Bovine Bone Particulate?

Xenograft Bovine Bone Particulate is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Collagen Solutions, LLC. The 510(k) number is K240133.

When did Xenograft Bovine Bone Particulate receive FDA 510(k) clearance?

Xenograft Bovine Bone Particulate received FDA 510(k) clearance on 2024-08-16, under 510(k) number K240133.

Who is the listed applicant for Xenograft Bovine Bone Particulate?

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

What is the FDA product code for Xenograft Bovine Bone Particulate?

The FDA product code for Xenograft Bovine Bone Particulate is NPM.

Related Clinical Trials

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.

NCT03943680Plasma Rich in Growth Factors in Post-extraction SocketsCOMPLETEDNCT07078331Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge AugmentationsACTIVE_NOT_RECRUITINGNCT07546279The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.RECRUITING

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 AGK230305THE Graft CollagenPurgo Biologics, Inc.K240661Geistlich Bio-Oss®Geistlich Pharma AG

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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