BIODHOC— 510(k) K024185

Name: FDA 510(k) clearance K024185
Creator: U.S. Food and Drug Administration
Published: 2004-01-15

Substantially Equivalent

Future Medical Systems, SA

FDA 510(k) clearance K024185 for BIODHOC, Substantially Equivalent on 2004-01-15. Applicant: Future Medical Systems, SA. Device class: 2.

Clearance details

Applicant: Future Medical Systems, SA
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2002-12-19
Decision date: 2004-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glen Burnie, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTY

view all

K262722 — Primal K-Wire (P99-193-1410)2026-08-28
K253325 — ZipToe Hammertoe Fusion System2025-12-29
K252657 — Impact PEEK Union Nail System2025-09-19
K250315 — RONAVIS FX (FX-001)2025-08-01
K251362 — PediFlex Flexible Nail System2025-06-24

More clearances from Future Medical Systems, SA

view all

K041824 — X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM2005-01-07

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.