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510(k) K151083

BioBridge Collagen Matrix by Fibralign Corporation — Product Code OWY

K151083 is an FDA 510(k) premarket notification submitted by Fibralign Corporation for the device "BioBridge Collagen Matrix". The FDA issued a decision of Substantially Equivalent on January 8, 2016. The device falls under product code OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2016
Date Received
April 22, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists in tendon repair.

Other clearances for product code OWY

  • K251690 — Arthrex SpeedFLEX™ Implant (September 30, 2025)
  • K252647 — Tapestry Biointegrative Implant (September 19, 2025)
  • K250109 — TYBR Collagen Gel (June 6, 2025)
  • K243843 — Tendon Protect (50242) (June 4, 2025)
  • K242631 — REGENETEN™ Bioinductive Implant (November 26, 2024)
  • K222501 — Regeneten Bioinductive Implant (May 11, 2023)
  • K220867 — Tapestry Biointegrative Implant (May 23, 2022)
  • K212306 — Tapestry Biointegrative Implant (November 2, 2021)
  • K201572 — TAPESTRY Biointegrative Implant (October 19, 2020)
  • K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI) (March 26, 2014)

FDA data resources