KESTREL POSTERIOR CERVICAL SPINE SYSTEM— 510(k) K132122

Name: FDA 510(k) clearance K132122
Creator: U.S. Food and Drug Administration
Published: 2014-01-22

Substantially Equivalent

Omni Surgical, LLC Dba Spine360

FDA 510(k) clearance K132122 for KESTREL POSTERIOR CERVICAL SPINE SYSTEM, Substantially Equivalent on 2014-01-22. Applicant: Omni Surgical, LLC Dba Spine360. Device class: 2.

Clearance details

Applicant: Omni Surgical, LLC Dba Spine360
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2013-07-10
Decision date: 2014-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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

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.