COFLEX-F— 510(k) K112595

Substantially Equivalent

Paradigm Spine, LLC

FDA 510(k) clearance K112595 for COFLEX-F, Substantially Equivalent on 2012-02-13. Applicant: Paradigm Spine, LLC.

Clearance details

Applicant: Paradigm Spine, LLC
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2011-09-07
Decision date: 2012-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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.