LTD POLYAXIAL FIXATION SYSTEM— 510(k) K062785

Name: FDA 510(k) clearance K062785
Creator: U.S. Food and Drug Administration
Published: 2006-12-26

Substantially Equivalent

Us Spine

FDA 510(k) clearance K062785 for LTD POLYAXIAL FIXATION SYSTEM, Substantially Equivalent on 2006-12-26. Applicant: Us Spine. Device class: 2.

Clearance details

Applicant: Us Spine
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2006-09-18
Decision date: 2006-12-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Apple Valley, MN, 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 Us Spine

view all

K082801 — PHANTOM PLUS CAGE SYSTEM2008-12-22
K081883 — MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM2008-09-24
K081296 — PREFERENCE PEDICLE SCREW SYSTEM2008-06-06
K061041 — US SPINE FACET FIXATION SYSTEM2006-06-19

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.