SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE— 510(k) K122518

Substantially Equivalent

Bm Korea Co., Ltd.

FDA 510(k) clearance K122518 for SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE, Substantially Equivalent on 2013-02-15. Applicant: Bm Korea Co., Ltd..

Clearance details

Applicant: Bm Korea Co., Ltd.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2012-08-17
Decision date: 2013-02-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Fullerton, CA, 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.