Fibralign Corporation

Address:32930 Alvrdo Niles Rd Ste 350,Union City,CA,94587,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (OWY) (1)

Premarket Exempt

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BioBridge® Collagen Matrix - B218PRT0070 Catalog Number : PRT0070

Device Description : The Fibralign BioBridge® Collagen Matrix is a sterile, thin collagen ribbon made The Fibralign BioBridge® Collagen Matrix is a sterile, thin collagen ribbon made of highly purified pepsin treated Type 1 porcine collagen and features Fibralign’s Nanoweave® technology. It is provided in single use packaging with five devices included in each package.

Device Class :

Duns Number: 023369802

Premarket Exempt : No

Product Code : OWY

Prescription Use : Yes

Device Count : 1

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