MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM— 510(k) K061576

Name: FDA 510(k) clearance K061576
Creator: U.S. Food and Drug Administration
Published: 2006-07-03

Substantially Equivalent

Quantum Orthopedics, Inc.

FDA 510(k) clearance K061576 for MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM, Substantially Equivalent on 2006-07-03. Applicant: Quantum Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Quantum Orthopedics, Inc.
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2006-06-07
Decision date: 2006-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

More clearances from Quantum Orthopedics, Inc.

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K062004 — MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT2006-08-15
K052641 — MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT2006-04-12
K060491 — QUANTUM ANTERIOR CERVICAL PLATE SYSTEM2006-03-13
K050449 — QUANTUM VERTEBRAL BODY REPLACEMENT2005-07-07

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.