SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)— 510(k) K082032

Substantially Equivalent

Abbott Spine, Inc.

FDA 510(k) clearance K082032 for SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310), Substantially Equivalent on 2008-10-06. Applicant: Abbott Spine, Inc..

Clearance details

Applicant: Abbott Spine, Inc.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2008-07-17
Decision date: 2008-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.