POWEREASE SYSTEM— 510(k) K123270

Name: FDA 510(k) clearance K123270
Creator: U.S. Food and Drug Administration
Published: 2013-01-11

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K123270 for POWEREASE SYSTEM, Substantially Equivalent on 2013-01-11. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code HBE
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 2012-10-19
Decision date: 2013-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.