MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT— 510(k) K052641

Substantially Equivalent

Quantum Orthopedics, Inc.

FDA 510(k) clearance K052641 for MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT, Substantially Equivalent on 2006-04-12. Applicant: Quantum Orthopedics, Inc..

Clearance details

Applicant: Quantum Orthopedics, Inc.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2005-09-26
Decision date: 2006-04-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, 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.