INNESIS PEEK CERVICAL CAGE— 510(k) K132483

Substantially Equivalent

Bk Meditech, Co., Ltd.

FDA 510(k) clearance K132483 for INNESIS PEEK CERVICAL CAGE, Substantially Equivalent on 2014-04-02. Applicant: Bk Meditech, Co., Ltd..

Clearance details

Applicant: Bk Meditech, Co., Ltd.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2013-08-08
Decision date: 2014-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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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.