ProMIS Fixation System— 510(k) K150380

Substantially Equivalent

Premia Spine, Ltd.

FDA 510(k) clearance K150380 for ProMIS Fixation System, Substantially Equivalent on 2015-07-17. Applicant: Premia Spine, Ltd..

Clearance details

Applicant: Premia Spine, Ltd.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2015-02-13
Decision date: 2015-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat Poleg, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.