ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM— 510(k) K013196

Name: FDA 510(k) clearance K013196
Creator: U.S. Food and Drug Administration
Published: 2002-01-30

Substantially Equivalent

Spinal Innovations, LLC

FDA 510(k) clearance K013196 for ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM, Substantially Equivalent on 2002-01-30. Applicant: Spinal Innovations, LLC. Device class: 2.

Clearance details

Applicant: Spinal Innovations, LLC
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2001-09-25
Decision date: 2002-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWP

view all

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 Spinal Innovations, LLC

view all

K022997 — SPECTRUM CERVICAL SPINAL SYSTEM2002-12-06
K010639 — CONVERGENCE CERVICAL SPINAL SYSTEM2001-05-30
K002069 — ASCEND SPINAL FIXATION SYSTEM2000-10-05

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.