NEXLINK OCT SYSTEM, MODEL 7000 SERIES— 510(k) K090060

Substantially Equivalent

Abbott Spine, Inc.

FDA 510(k) clearance K090060 for NEXLINK OCT SYSTEM, MODEL 7000 SERIES, Substantially Equivalent on 2009-06-02. Applicant: Abbott Spine, Inc..

Clearance details

Applicant: Abbott Spine, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2009-01-09
Decision date: 2009-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.