MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM— 510(k) K132900

Name: FDA 510(k) clearance K132900
Creator: U.S. Food and Drug Administration
Published: 2013-10-25

Substantially Equivalent

Intelligent Implant Systems, LLC

FDA 510(k) clearance K132900 for MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM, Substantially Equivalent on 2013-10-25. Applicant: Intelligent Implant Systems, LLC. Device class: 2.

Clearance details

Applicant: Intelligent Implant Systems, LLC
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2013-09-16
Decision date: 2013-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWP

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K143278 — LnK Posterior Cervical Fixation System2015-07-29
K150753 — OASYS System2015-06-09
K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System2015-06-04
K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

More clearances from Intelligent Implant Systems, LLC

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K173935 — Mediant Anterior Cervical Plating System2018-04-16
K163056 — Revolution Spinal Fixation System2017-02-24
K160216 — Revolution Spinal Fixation System2016-04-22
K142939 — Revolution Spinal Fixation System2015-01-13
K121682 — ACTIVE SCREW BONE SCREW2012-10-04

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.