MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM— 510(k) K080790

Name: FDA 510(k) clearance K080790
Creator: U.S. Food and Drug Administration
Published: 2008-04-29

Substantially Equivalent

Theken Spine, LLC

FDA 510(k) clearance K080790 for MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM, Substantially Equivalent on 2008-04-29. Applicant: Theken Spine, LLC. Device class: 2.

Clearance details

Applicant: Theken Spine, LLC
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2008-03-20
Decision date: 2008-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Akron, OH, 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 Theken Spine, LLC

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K121482 — INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY2012-08-28
K121211 — VU APOD INTERVERTEBRAL BODY FUSION DEVICE2012-06-27
K120829 — STAINLESS STEEL SPINAL SYSTEM2012-05-30
K120047 — CORAL SPINAL SYSTEM2012-02-03
K111675 — VU C*POD INTERVERTEBRAL BODY FUSION DEVICE2011-08-02

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.