BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)— 510(k) K030581

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K030581 for BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION), Substantially Equivalent on 2003-06-26. Applicant: Blackstone Medical, Inc..

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2003-02-24
Decision date: 2003-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Springfield, MA, 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.