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510(k) K201572

TAPESTRY Biointegrative Implant by Embody, Inc. — Product Code OWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2020
Date Received
June 11, 2020
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 by Embody, Inc.

  • K252647 — Tapestry Biointegrative Implant (September 19, 2025)
  • K223822 — ACTIVBRAID™ (June 2, 2023)
  • K220867 — Tapestry Biointegrative Implant (May 23, 2022)
  • K213958 — Bioabsorbable Anchor (April 8, 2022)
  • K212306 — Tapestry Biointegrative Implant (November 2, 2021)

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)
  • K151083 — BioBridge Collagen Matrix (January 8, 2016)
  • K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI) (March 26, 2014)