LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU— 510(k) K132644

Name: FDA 510(k) clearance K132644
Creator: U.S. Food and Drug Administration
Published: 2013-09-19

Substantially Equivalent

Corentec Co., Ltd.

FDA 510(k) clearance K132644 for LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU, Substantially Equivalent on 2013-09-19. Applicant: Corentec Co., Ltd.. Device class: 2.

Clearance details

Applicant: Corentec Co., Ltd.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2013-08-26
Decision date: 2013-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Seocho Gu, Seoul, KR

Download summary PDF View on FDA.gov ↗

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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.