Lapidus Screw Kit— 510(k) K262075

Name: FDA 510(k) clearance K262075
Creator: U.S. Food and Drug Administration
Published: 2026-07-22

Substantially Equivalent

Relja Innovations, LLC

FDA 510(k) clearance K262075 for Lapidus Screw Kit, Substantially Equivalent on 2026-07-22. Applicant: Relja Innovations, LLC. Device class: 2.

Clearance details

Applicant: Relja Innovations, LLC
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-06-22
Decision date: 2026-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

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K261154 — CoLink® & CoLag® Non-Sterile Screws2026-05-30
K261241 — TriMed Compression Screws2026-05-14
K254215 — Arthrex Beaming System2026-05-08

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.