HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES— 510(k) K100614

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K100614 for HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES, Substantially Equivalent on 2010-05-04. Applicant: Blackstone Medical, Inc..

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2010-03-04
Decision date: 2010-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.