Prase PEEK Anterior Cervical Interbody Spacer— 510(k) K202872

Substantially Equivalent

Gbs Commonwealth Co., Ltd.

FDA 510(k) clearance K202872 for Prase PEEK Anterior Cervical Interbody Spacer, Substantially Equivalent on 2021-02-04. Applicant: Gbs Commonwealth Co., Ltd..

Clearance details

Applicant: Gbs Commonwealth Co., Ltd.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2020-09-28
Decision date: 2021-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geumcheon-Gu, KR

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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.