ALPHA ORTHOPAEDICS AT2 SYSTEM— 510(k) K120527

Name: FDA 510(k) clearance K120527
Creator: U.S. Food and Drug Administration
Published: 2012-06-18

Substantially Equivalent

Alpha Orthopaedics, Inc.

FDA 510(k) clearance K120527 for ALPHA ORTHOPAEDICS AT2 SYSTEM, Substantially Equivalent on 2012-06-18. Applicant: Alpha Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: Alpha Orthopaedics, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2012-02-22
Decision date: 2012-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.