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FDA 510(k)

Anorganic Bone Mineral with Collagen in Delivery Applicator

K-Number: K171008 · 2017-10-30

ApplicantCollagen Matrix, Inc.
Decision Date2017-10-30
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Anorganic Bone Mineral with Collagen in Delivery Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K171008. 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 Anorganic Bone Mineral with Collagen in Delivery Applicator?

Anorganic Bone Mineral with Collagen in Delivery Applicator is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K171008.

When did Anorganic Bone Mineral with Collagen in Delivery Applicator receive FDA 510(k) clearance?

Anorganic Bone Mineral with Collagen in Delivery Applicator received FDA 510(k) clearance on 2017-10-30, under 510(k) number K171008.

Who is the listed applicant for Anorganic Bone Mineral with Collagen in Delivery Applicator?

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

What is the FDA product code for Anorganic Bone Mineral with Collagen in Delivery Applicator?

The FDA product code for Anorganic Bone Mineral with Collagen in Delivery Applicator is NPM.

Related Clinical Trials

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Other records listing Collagen Matrix, 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.

K251191Collagen Dura Regeneration Membrane - RepairK243071Bovine Dermis Collagen Dermal MatrixK242302RejuvaKnee™ Collagen Meniscus ImplantK233203Soft Tissue Augmentation Resorbable MatrixK240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixK231942Mineral Collagen Composite Bioactive Extra Moldable

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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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