MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM— 510(k) K042514

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K042514 for MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM, Substantially Equivalent on 2004-10-07. Applicant: Blackstone Medical, Inc..

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2004-09-16
Decision date: 2004-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Springfield, MA, US

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.