FDA 510(k)

BioBridge Collagen Matrix

K-Number: K151083 · 2016-01-08

Decision Date2016-01-08

Product CodeOWY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BioBridge Collagen Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Fibralign Corporation. It received FDA 510(k) clearance on 2016-01-08 under 510(k) number K151083. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioBridge Collagen Matrix?

BioBridge Collagen Matrix is a medical device that received FDA 510(k) clearance on 2016-01-08. The listed applicant is Fibralign Corporation. The 510(k) number is K151083.

When did BioBridge Collagen Matrix receive FDA 510(k) clearance?

BioBridge Collagen Matrix received FDA 510(k) clearance on 2016-01-08, under 510(k) number K151083.

Who is the listed applicant for BioBridge Collagen Matrix?

The FDA 510(k) record lists Fibralign Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioBridge Collagen Matrix?

The FDA product code for BioBridge Collagen Matrix is OWY.

Related Devices (Code: OWY)

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.

K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.K252647Tapestry Biointegrative ImplantEmbody, Inc.K250109TYBR Collagen GelTybr Health K243843Tendon Protect (50242)Kerecis Limited K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.