CERTEX SPINAL IMPLANT SYSTEM— 510(k) K122163

Substantially Equivalent

X-Spine Systems, Inc.

FDA 510(k) clearance K122163 for CERTEX SPINAL IMPLANT SYSTEM, Substantially Equivalent on 2012-10-31. Applicant: X-Spine Systems, Inc..

Clearance details

Applicant: X-Spine Systems, Inc.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2012-07-20
Decision date: 2012-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, US

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.