NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY— 510(k) K052566

Name: FDA 510(k) clearance K052566
Creator: U.S. Food and Drug Administration
Published: 2006-01-06

Substantially Equivalent

Abbott Spine, Inc.

FDA 510(k) clearance K052566 for NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY, Substantially Equivalent on 2006-01-06. Applicant: Abbott Spine, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Spine, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2005-09-19
Decision date: 2006-01-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, 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.