Spine Wave Anterior Cervical Spine System— 510(k) K162760

Clearance details

Applicant

Spine Wave, Inc.

Product code

Code OVE

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2016-09-30

Decision date

2017-02-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shelton, CT, US

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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 →