Unison-C Anterior Cervical Fixation System— 510(k) K170830

Clearance details

Applicant

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

Product code

Code OVE

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2017-03-20

Decision date

2017-06-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marquette, MI, US

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• K192718 — Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology2019-12-20

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 →