LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)— 510(k) K100191

Name: FDA 510(k) clearance K100191
Creator: U.S. Food and Drug Administration
Published: 2010-04-15

Substantially Equivalent

Lanx, Inc.

FDA 510(k) clearance K100191 for LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS), Substantially Equivalent on 2010-04-15. Applicant: Lanx, Inc.. Device class: 2.

Clearance details

Applicant: Lanx, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2010-01-22
Decision date: 2010-04-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Broomfield, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWP

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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 Lanx, Inc.

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K131547 — LANX FUSION SYSTEM2013-07-12
K131156 — LANX SPINAL FIXATION SYSTEM2013-05-24
K123767 — LANX FUSION SYSTEM- SA2013-03-18
K121316 — LANX SPINAL FIZATION SYSTEM2012-09-10
K122145 — LANX SPINAL FIXATION SYSTEM2012-08-17

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.