ULC SPINAL PEDICLE SCREW SYSTEM— 510(k) K083077

Name: FDA 510(k) clearance K083077
Creator: U.S. Food and Drug Administration
Published: 2009-10-26

Substantially Equivalent

Otis Biotech Co., Ltd.

FDA 510(k) clearance K083077 for ULC SPINAL PEDICLE SCREW SYSTEM, Substantially Equivalent on 2009-10-26. Applicant: Otis Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Otis Biotech Co., Ltd.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2008-10-16
Decision date: 2009-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Siheung-Si, Gyounggi-Do, KR

Download summary PDF View on FDA.gov ↗

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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.