GSO GS1 SPACER— 510(k) K071274

Substantially Equivalent

Gold Standard Orthopedics, LLC

FDA 510(k) clearance K071274 for GSO GS1 SPACER, Substantially Equivalent on 2007-08-24. Applicant: Gold Standard Orthopedics, LLC.

Clearance details

Applicant: Gold Standard Orthopedics, LLC
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2007-05-07
Decision date: 2007-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.