CERTEX OCT SPINAL IMPLANT SYSTEM— 510(k) K133094

Substantially Equivalent

X-Spine Systems, Inc.

FDA 510(k) clearance K133094 for CERTEX OCT SPINAL IMPLANT SYSTEM, Substantially Equivalent on 2013-12-11. Applicant: X-Spine Systems, Inc..

Clearance details

Applicant: X-Spine Systems, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2013-09-30
Decision date: 2013-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, 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.