Sure Lok Mini Posterior Cervical/Upper Thoracic System— 510(k) K150851

Name: FDA 510(k) clearance K150851
Creator: U.S. Food and Drug Administration
Published: 2015-06-04

Substantially Equivalent

Precision Spine, Inc.

FDA 510(k) clearance K150851 for Sure Lok Mini Posterior Cervical/Upper Thoracic System, Substantially Equivalent on 2015-06-04. Applicant: Precision Spine, Inc.. Device class: 2.

Clearance details

Applicant: Precision Spine, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2015-03-31
Decision date: 2015-06-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Pear, MS, US

Download summary PDF View on FDA.gov ↗

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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.