SPIDER SYSTEM KOLIBRI CEMENT NEEDLE— 510(k) K130402

Name: FDA 510(k) clearance K130402
Creator: U.S. Food and Drug Administration
Published: 2013-04-01

Substantially Equivalent

Sintea Plustek, LLC

FDA 510(k) clearance K130402 for SPIDER SYSTEM KOLIBRI CEMENT NEEDLE, Substantially Equivalent on 2013-04-01. Applicant: Sintea Plustek, LLC. Device class: 2.

Clearance details

Applicant: Sintea Plustek, LLC
Product code: Code NDN
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2013-02-19
Decision date: 2013-04-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Apple Valley, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.