OsteoSinter® EVANS and COTTON wedges and related accessories— 510(k) K240461

Name: FDA 510(k) clearance K240461
Creator: U.S. Food and Drug Administration
Published: 2024-12-06

Substantially Equivalent

Ames Medical Prosthetic Solutions, S.A.U.

FDA 510(k) clearance K240461 for OsteoSinter® EVANS and COTTON wedges and related accessories, Substantially Equivalent on 2024-12-06. Applicant: Ames Medical Prosthetic Solutions, S.A.U.. Device class: 2.

Clearance details

Applicant: Ames Medical Prosthetic Solutions, S.A.U.
Product code: Code PLF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-02-16
Decision date: 2024-12-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sant Feliu De Llobregat, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLF

view all

K252733 — ATLAS Expandable Osteotomy Wedge System2026-02-19
K252254 — Osteotomy Wedge System2025-10-17
K251791 — Auxano® Wedge Fixation System2025-09-25
K243231 — Trigon PEEK HA Wedges2024-11-08
K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System2024-01-26

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