Data / Medical devices / United States / Embody, Inc.
Embody, Inc.: FDA-registered device maker in Norfolk, VA, United States, 6 510(k) clearances
Embody, Inc. is registered with the FDA (registration 3015543569) in Norfolk, VA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 19, 2025. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015543569
- Address
- 4211 Monarch Way Suite 500, Norfolk, VA, United States, 23508
- Owner or operator
- Embody, Inc. (10079091)
- Roles
- Manufacturer
- First device listed
- November 18, 2020
- Registered through
- 2027
- Brand names listed
- ActivBraid, Dual Anchor Inserter with Bioabsorbable Anchors, Tapestry Biointegrative Implant, Tapestry Biointegrative Implant with Introducer, Tapestry RC Biointegrative Implant System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Tray | OJH | 1 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 19, 2025 | K252647 | Tapestry Biointegrative Implant | OWY | Substantially Equivalent | Embody, Inc. | accessdata.fda.gov |
| June 2, 2023 | K223822 | ACTIVBRAID | GAT | Substantially Equivalent | Embody, Inc. | accessdata.fda.gov |
| May 23, 2022 | K220867 | Tapestry Biointegrative Implant | OWY | Substantially Equivalent | Embody, Inc. | accessdata.fda.gov |
| April 8, 2022 | K213958 | Bioabsorbable Anchor | MAI | Substantially Equivalent | Embody, Inc. | accessdata.fda.gov |
| November 2, 2021 | K212306 | Tapestry Biointegrative Implant | OWY | Substantially Equivalent | Embody, Inc. | accessdata.fda.gov |
| October 19, 2020 | K201572 | TAPESTRY Biointegrative Implant | OWY | Substantially Equivalent | Embody, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- All makers of Orthopedic Tray
- All makers of Mesh, Surgical
Updated September 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.