DENALI DEFORMITY SYSTEM— 510(k) K052404

Name: FDA 510(k) clearance K052404
Creator: U.S. Food and Drug Administration
Published: 2006-05-23

Substantially Equivalent

K2m, LLC

FDA 510(k) clearance K052404 for DENALI DEFORMITY SYSTEM, Substantially Equivalent on 2006-05-23. Applicant: K2m, LLC. Device class: 2.

Clearance details

Applicant: K2m, LLC
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2005-09-01
Decision date: 2006-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

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K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

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K060442 — PYRENEES CERVICAL PLATE SYSTEM2006-05-15
K052398 — MESA SPINAL SYSTEM2005-12-07
K051531 — TECTONIC CERVICAL PLATE SYSTEM2005-10-17

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.