ACUMED SUTURE ANCHOR SYSTEM— 510(k) K140925

Name: FDA 510(k) clearance K140925
Creator: U.S. Food and Drug Administration
Published: 2014-05-20

Substantially Equivalent

Acumed, LLC

FDA 510(k) clearance K140925 for ACUMED SUTURE ANCHOR SYSTEM, Substantially Equivalent on 2014-05-20. Applicant: Acumed, LLC. Device class: 2.

Clearance details

Applicant: Acumed, LLC
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2014-04-11
Decision date: 2014-05-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Hillsboro, OR, US

Download summary PDF View on FDA.gov ↗

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K251296 — The Acumed Wrist Fixation System2025-06-18
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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.