SF Push- in Anchor— 510(k) K240288

Name: FDA 510(k) clearance K240288
Creator: U.S. Food and Drug Administration
Published: 2024-04-01

Substantially Equivalent

Surgical Fusion Technologies GmbH

FDA 510(k) clearance K240288 for SF Push- in Anchor, Substantially Equivalent on 2024-04-01. Applicant: Surgical Fusion Technologies GmbH. Device class: 2.

Clearance details

Applicant: Surgical Fusion Technologies GmbH
Product code: Code MAI
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-02-01
Decision date: 2024-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schlieren, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAI

view all

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

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.