Shanghai Sanyou CARMEN Cervical Fusion System— 510(k) K163366

Clearance details

Applicant

Shanghai Sanyou Medical Co, Ltd.

Product code

Code KWQ

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2016-11-30

Decision date

2017-10-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Jiading District, CN

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• K211689 — KEYSTONE PEEK Cage System2021-09-21
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Death

8

Injury

1,212

Malfunction

1,233

Total

2,453

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 →