NEXTGEN ALTIUS OCT SYSTEM— 510(k) K113593

Substantially Equivalent

Biomet Spine (Aka Ebi, LLC)

FDA 510(k) clearance K113593 for NEXTGEN ALTIUS OCT SYSTEM, Substantially Equivalent on 2012-04-17. Applicant: Biomet Spine (Aka Ebi, LLC).

Clearance details

Applicant: Biomet Spine (Aka Ebi, LLC)
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2011-12-05
Decision date: 2012-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.