PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES— 510(k) K100845

Substantially Equivalent

Zimmer Spine, Inc.

FDA 510(k) clearance K100845 for PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES, Substantially Equivalent on 2010-09-21. Applicant: Zimmer Spine, Inc..

Clearance details

Applicant: Zimmer Spine, Inc.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2010-03-25
Decision date: 2010-09-21
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.