CADENCE CEMENT RESTRICTOR— 510(k) K022218

Name: FDA 510(k) clearance K022218
Creator: U.S. Food and Drug Administration
Published: 2002-08-12

Substantially Equivalent

Spinal Concepts, Inc.

FDA 510(k) clearance K022218 for CADENCE CEMENT RESTRICTOR, Substantially Equivalent on 2002-08-12. Applicant: Spinal Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Spinal Concepts, Inc.
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2002-07-09
Decision date: 2002-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDK

view all

K210062 — Mectaplug PE II2021-04-08
K061465 — KMI CEMENT RESTRICTOR IMPLANT2006-10-05
K061698 — MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR2006-07-12
K060247 — LIFE SPINE CEMENT RESTRICTOR2006-05-11
K060132 — SPINAL USA CEMENT RESTRICTOR SYSTEM2006-03-16

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
K040096 — SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM2004-07-01
K033663 — SPINAL CONCEPTS INC. CODA2004-05-27
K033517 — SPINAL CONCEPTS INC. CADENCE AND TRAXIS2004-02-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.