BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020— 510(k) K061162

Substantially Equivalent

Applied Spine Technologies, Inc.

FDA 510(k) clearance K061162 for BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020, Substantially Equivalent on 2006-07-26. Applicant: Applied Spine Technologies, Inc..

Clearance details

Applicant: Applied Spine Technologies, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2006-04-26
Decision date: 2006-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Haven, CT, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.