Bioabsorbable Anchor— 510(k) K213958

Name: FDA 510(k) clearance K213958
Creator: U.S. Food and Drug Administration
Published: 2022-04-08

Substantially Equivalent

Embody, Inc.

FDA 510(k) clearance K213958 for Bioabsorbable Anchor, Substantially Equivalent on 2022-04-08. Applicant: Embody, Inc.. Device class: 2.

Clearance details

Applicant: Embody, Inc.
Product code: Code MAI
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2021-12-17
Decision date: 2022-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norfolk, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAI

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K262357 — Arthrex Bioabsorbable PushLock Suture Anchors2026-08-07
K253931 — Arthrex Bioabsorbable PushLock Suture Anchors2026-05-28
K260294 — SF Push-in Anchor2026-03-27
K254055 — OSSIOfiber® Suture Anchor2026-02-24
K251680 — Biosteon® Screw2026-02-17

More clearances from Embody, Inc.

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K252647 — Tapestry Biointegrative Implant2025-09-19
K223822 — ACTIVBRAID2023-06-02
K220867 — Tapestry Biointegrative Implant2022-05-23
K212306 — Tapestry Biointegrative Implant2021-11-02
K201572 — TAPESTRY Biointegrative Implant2020-10-19

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.