POLYAXIAL HEMISPHERICAL SPINAL SCREWS— 510(k) K051063

Name: FDA 510(k) clearance K051063
Creator: U.S. Food and Drug Administration
Published: 2005-05-23

Substantially Equivalent

Scient'X

FDA 510(k) clearance K051063 for POLYAXIAL HEMISPHERICAL SPINAL SCREWS, Substantially Equivalent on 2005-05-23. Applicant: Scient'X. Device class: 2.

Clearance details

Applicant: Scient'X
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2005-04-26
Decision date: 2005-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, US

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.