Shanghai Sanyou PEEK Cage System— 510(k) K163422

Substantially Equivalent

Shanghai Sanyou Medical Co, Ltd.

FDA 510(k) clearance K163422 for Shanghai Sanyou PEEK Cage System, Substantially Equivalent on 2017-09-18. Applicant: Shanghai Sanyou Medical Co, Ltd..

Clearance details

Applicant: Shanghai Sanyou Medical Co, Ltd.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2016-12-06
Decision date: 2017-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiading District, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.