Reform® POCT System— 510(k) K162300

Substantially Equivalent

Precision Spine, Inc.

FDA 510(k) clearance K162300 for Reform® POCT System, Substantially Equivalent on 2016-11-22. Applicant: Precision Spine, Inc..

Clearance details

Applicant: Precision Spine, Inc.
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2016-08-16
Decision date: 2016-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pear, MS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.