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FDA 510(k)

BioBridge Collagen Matrix

K-Number: K151083 · 2016-01-08

ApplicantFibralign Corporation
Decision Date2016-01-08
Product CodeOWY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BioBridge Collagen Matrix is a medical device manufactured by Fibralign Corporation. It received FDA 510(k) clearance on 2016-01-08 under approval 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. It is manufactured by Fibralign Corporation. The 510(k) number is K151083.

When was BioBridge Collagen Matrix approved by the FDA?

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

What company makes BioBridge Collagen Matrix?

BioBridge Collagen Matrix is manufactured by Fibralign Corporation.

What is the FDA product code for BioBridge Collagen Matrix?

The FDA product code for BioBridge Collagen Matrix is OWY.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT05081284 Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix ACTIVE_NOT_RECRUITING NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT07219316 Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision COMPLETED

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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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