510(k) Report

FDA applicant

Embody, Inc.

Norfolk, VA6 decisions2020–20250 recalls

FDA records 6 decisions for Embody, Inc. (Norfolk, VA) from 2020 to 2025: 6 510(k) clearances. Most are in product codes OWY (Mesh, Surgical, Collagen, Orthopaedics…) and MAI (Fastener, Fixation, Biodegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 112 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Embody, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 12021: 12022: 22023: 12025: 1
2020high 2 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Embody, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Embody, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon4decisions
  • MAIFastener, Fixation, Biodegradable, Soft Tissue1decision
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 112 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 136 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201572TAPESTRY Biointegrative ImplantEmbody, Inc. · 20203cite it
  • K212306Tapestry Biointegrative ImplantEmbody, Inc. · 20212cite it

What has FDA decided for it lately?

  • K252647Tapestry Biointegrative ImplantEmbody, Inc. · 2025
  • K223822Activbraid™Embody, Inc. · 2023
  • K220867Tapestry Biointegrative ImplantEmbody, Inc. · 2022
  • K213958Bioabsorbable AnchorEmbody, Inc. · 2022
  • K212306Tapestry Biointegrative ImplantEmbody, Inc. · 2021
  • K201572TAPESTRY Biointegrative ImplantEmbody, Inc. · 2020

All 6 as Embody, Inc. →