6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor— 510(k) K201883

Name: FDA 510(k) clearance K201883
Creator: U.S. Food and Drug Administration
Published: 2020-08-07

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K201883 for 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor, Substantially Equivalent on 2020-08-07. Applicant: Medos International SARL. Device class: 2.

Clearance details

Applicant: Medos International SARL
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2020-07-08
Decision date: 2020-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Le Locle, CH

Download summary PDF View on FDA.gov ↗

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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.