SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM— 510(k) K120353

Substantially Equivalent

Bm Korea Co., Ltd.

FDA 510(k) clearance K120353 for SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM, Substantially Equivalent on 2012-05-09. Applicant: Bm Korea Co., Ltd..

Clearance details

Applicant: Bm Korea Co., Ltd.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2012-02-06
Decision date: 2012-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.