STERISPINE CC— 510(k) K162531

Clearance details

Applicant

Safe Orthopaedics

Product code

Code OVE

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2016-09-09

Decision date

2016-12-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Eragny Sur Oise, FR

• K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
• K261451 — ZSAlign Cervical Interbody System2026-07-31
• K262094 — E3D-C Interbody System2026-07-22
• K261279 — DeltaNEC Interbody System2026-06-22
• K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

• K201648 — Sterispine PS2020-07-30
• K170528 — Sterispine PS2017-03-09
• K151921 — STERISPINE PS2015-10-08
• K151747 — STERISPINE PS2015-10-05
• K151756 — STERISPINE LC CAGE2015-08-21

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 →