SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM— 510(k) K040096

Name: FDA 510(k) clearance K040096
Creator: U.S. Food and Drug Administration
Published: 2004-07-01

Substantially Equivalent

Spinal Concepts, Inc.

FDA 510(k) clearance K040096 for SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM, Substantially Equivalent on 2004-07-01. Applicant: Spinal Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Spinal Concepts, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2004-01-20
Decision date: 2004-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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 Concepts, Inc.

view all

K051000 — FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE2005-05-19
K050706 — HARMONY PORT SYSTEM, MODEL 1907 SERIES2005-04-15
K033663 — SPINAL CONCEPTS INC. CODA2004-05-27
K033517 — SPINAL CONCEPTS INC. CADENCE AND TRAXIS2004-02-18
K031855 — SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM2003-09-17

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.