PALLS M SPINAL SYSTEM— 510(k) K120538

Substantially Equivalent

Korea Bone Bank Co., Ltd.

FDA 510(k) clearance K120538 for PALLS M SPINAL SYSTEM, Substantially Equivalent on 2012-03-23. Applicant: Korea Bone Bank Co., Ltd..

Clearance details

Applicant: Korea Bone Bank Co., Ltd.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2012-02-22
Decision date: 2012-03-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.