PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS— 510(k) K071174

Substantially Equivalent

Abbott Spine, Inc.

FDA 510(k) clearance K071174 for PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS, Substantially Equivalent on 2007-07-25. Applicant: Abbott Spine, Inc..

Clearance details

Applicant: Abbott Spine, Inc.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2007-04-27
Decision date: 2007-07-25
Decision: Substantially Equivalent
Clearance type: Special
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.