510(k) K080790— MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM

Substantially Equivalent

Theken Spine, LLC

Clearance details

Applicant: Theken Spine, LLC
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2008-03-20
Decision date: 2008-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Akron, OH, US

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.