CADENCE SPINAL FIXATION SYSTEM— 510(k) K022374

Clearance details

Applicant

Sulzer Spine-Tech

Product code

Code KWP

Device class

Class 2

Regulation

21 CFR 888.3050

Advisory panel

Orthopedic

Date received

2002-07-22

Decision date

2002-09-24

Decision

Substantially Equivalent

Clearance type

Special

Location

Minneapolis, MN, US

• 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

• K020344 — RPX TITANIUM CEMNT RESTRICTOR2002-05-02
• K020196 — MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM2002-02-15
• K012173 — DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM2001-09-28
• K012305 — MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM2001-08-22
• K993067 — SILHOUETTE SPINAL FIXATION SYSTEM1999-11-16

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 →