SF Push-in Anchor— 510(k) K260294

Name: FDA 510(k) clearance K260294
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Substantially Equivalent

Surgical Fusion Technologies GmbH

FDA 510(k) clearance K260294 for SF Push-in Anchor, Substantially Equivalent on 2026-03-27. Applicant: Surgical Fusion Technologies GmbH. Device class: 2.

Summary

Surgical Fusion Technologies' SF Push-in Anchor is filed under MAI, biodegradable soft tissue fixation fasteners. The record doesn't list sizes.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Surgical Fusion Technologies filed from Schlieren, Switzerland. Review took 57 calendar days (January 29 to March 27, 2026).

Clearance details

Applicant: Surgical Fusion Technologies GmbH
Product code: Product code MAI
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-01-29
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schlieren, CH

Download summary PDF View on FDA.gov ↗

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K240288 — SF Push- in Anchor2024-04-01

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.