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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Collagen Dura Regeneration Membrane - Repair

Manufacturer

Collagen Matrix, Inc.

Date Cleared

2025-11-18

(215 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K141608,K040888,K161370

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Collagen Dura Regeneration Membrane - Repair is indicated as a dura substitute for the repair of dura mater.

Device Description

Collagen Dura Regeneration Membrane - Repair is a white, nonfriable, resorbable, membrane matrix consisting of highly purified Type I and Type III collagen from bovine dermis for the repair of defects in dura mater.

Collagen Dura Regeneration Membrane - Repair is provided in various sizes where it can be easily trimmed for an appropriate fit.

Collagen Dura Regeneration Membrane - Repair is supplied sterile, non-pyrogenic and for single use only.

AI/ML Overview

N/A

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