Caspian OCT/MESA Mini/DENALI Mini Spinal System— 510(k) K142558

Substantially Equivalent

K2m

FDA 510(k) clearance K142558 for Caspian OCT/MESA Mini/DENALI Mini Spinal System, Substantially Equivalent on 2014-12-22. Applicant: K2m.

Clearance details

Applicant: K2m
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2014-09-11
Decision date: 2014-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, 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.