Unison-C Anterior Cervical Fixation System— 510(k) K152793

Substantially Equivalent

Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

FDA 510(k) clearance K152793 for Unison-C Anterior Cervical Fixation System, Substantially Equivalent on 2016-01-19. Applicant: Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc..

Clearance details

Applicant: Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2015-09-28
Decision date: 2016-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.