SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM— 510(k) K103383

Substantially Equivalent

Spartek Medical, Inc.

FDA 510(k) clearance K103383 for SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM, Substantially Equivalent on 2011-02-17. Applicant: Spartek Medical, Inc..

Clearance details

Applicant: Spartek Medical, Inc.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2010-11-18
Decision date: 2011-02-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Alameda, CA, 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.