SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)— 510(k) K983197

Clearance details

Applicant

United States Surgical, A Division of Tyco Healthc

Product code

Code KWP

Device class

Class 2

Regulation

21 CFR 888.3050

Advisory panel

Orthopedic

Date received

1998-09-11

Decision date

1998-10-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Norwalk, CT, 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

• K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER2007-11-21
• K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR2007-09-28
• K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER2006-11-02
• K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS2006-10-23
• K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE2006-09-01

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 →