NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES— 510(k) K062505

Substantially Equivalent

Abbott Spine, Inc.

FDA 510(k) clearance K062505 for NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES, Substantially Equivalent on 2006-09-26. Applicant: Abbott Spine, Inc..

Clearance details

Applicant: Abbott Spine, Inc.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2006-08-28
Decision date: 2006-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

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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.