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FDA 510(k)

OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS

K-Number: K043034 · 2005-08-04

ApplicantCollagen Matrix, Inc.
Decision Date2005-08-04
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS 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 2005-08-04 under 510(k) number K043034. 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 OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS?

OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS is a medical device that received FDA 510(k) clearance on 2005-08-04. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K043034.

When did OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS receive FDA 510(k) clearance?

OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS received FDA 510(k) clearance on 2005-08-04, under 510(k) number K043034.

Who is the listed applicant for OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS?

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 OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS?

The FDA product code for OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS 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.

K254210REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)Hyundai Bioland Co., Ltd.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, LLC

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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