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FDA 510(k)

Porcine Anorganic Bone Mineral in Delivery Applicator

K-Number: K162158 · 2017-02-09

ApplicantCollagen Matrix, Inc.
Decision Date2017-02-09
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Porcine Anorganic Bone Mineral 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 2017-02-09 under 510(k) number K162158. 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 Porcine Anorganic Bone Mineral in Delivery Applicator?

Porcine Anorganic Bone Mineral in Delivery Applicator is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K162158.

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

Porcine Anorganic Bone Mineral in Delivery Applicator received FDA 510(k) clearance on 2017-02-09, under 510(k) number K162158.

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

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

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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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