SMALL STATURE SPACERS— 510(k) K063393

Substantially Equivalent

Biomet Spine

FDA 510(k) clearance K063393 for SMALL STATURE SPACERS, Substantially Equivalent on 2007-06-25. Applicant: Biomet Spine.

Clearance details

Applicant: Biomet Spine
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2006-11-09
Decision date: 2007-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, 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.