BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS— 510(k) K041939

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K041939 for BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS, Substantially Equivalent on 2004-08-17. Applicant: Blackstone Medical, Inc..

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2004-07-19
Decision date: 2004-08-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Springfield, MA, US

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.