AXLE INTERSPINOUS FUSION SYSTEM— 510(k) K101471

Name: FDA 510(k) clearance K101471
Creator: U.S. Food and Drug Administration
Published: 2010-11-24

Substantially Equivalent

X-Spine Systems, Inc.

FDA 510(k) clearance K101471 for AXLE INTERSPINOUS FUSION SYSTEM, Substantially Equivalent on 2010-11-24. 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: 2010-05-27
Decision date: 2010-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, US

Download summary PDF View on FDA.gov ↗

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K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

More clearances from X-Spine Systems, Inc.

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K170119 — Calix Lumbar Spinal Implant System2017-09-29
K171567 — IRIX-A Lumbar Integrated Fusion System2017-08-28
K171075 — Calix-C Cervical Interbody Spacer2017-08-01

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.