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510(k) K252647

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2025
Date Received
August 21, 2025
Clearance Type
Special
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.

  • 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)
  • K201572 — TAPESTRY Biointegrative Implant (October 19, 2020)

Other clearances for product code OWY

  • K251690 — Arthrex SpeedFLEX™ Implant (September 30, 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)
  • K151083 — BioBridge Collagen Matrix (January 8, 2016)
  • K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI) (March 26, 2014)