AXLE PEEK INTERSPINOUS FUSION SYSTEM— 510(k) K112592

Name: FDA 510(k) clearance K112592
Creator: U.S. Food and Drug Administration
Published: 2011-12-05

Substantially Equivalent

X-Spine Systems, Inc.

FDA 510(k) clearance K112592 for AXLE PEEK INTERSPINOUS FUSION SYSTEM, Substantially Equivalent on 2011-12-05. Applicant: X-Spine Systems, Inc.. Device class: 2.

Clearance details

Applicant: X-Spine Systems, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2011-09-07
Decision date: 2011-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Miamisburg, OH, US

Download summary PDF View on FDA.gov ↗

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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.