POLYBONE GRANULE & BLOCK— 510(k) K082338

Substantially Equivalent

Kyung Won Medical Co., Ltd.

FDA 510(k) clearance K082338 for POLYBONE GRANULE & BLOCK, Substantially Equivalent on 2008-10-16. Applicant: Kyung Won Medical Co., Ltd..

Clearance details

Applicant: Kyung Won Medical Co., Ltd.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2008-08-14
Decision date: 2008-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.