NOVEL VBR SPINAL SYSTEM— 510(k) K050553

Name: FDA 510(k) clearance K050553
Creator: U.S. Food and Drug Administration
Published: 2005-04-18

Substantially Equivalent

Alphatec/Nexmed

FDA 510(k) clearance K050553 for NOVEL VBR SPINAL SYSTEM, Substantially Equivalent on 2005-04-18. Applicant: Alphatec/Nexmed. Device class: 2.

Clearance details

Applicant: Alphatec/Nexmed
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2005-03-03
Decision date: 2005-04-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQP

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

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K050830 — ZODIAC SPINAL FIXATION SYSTEM2005-06-22
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K050390 — TAMARACK ANTERIOR THORACOLUNBAR2005-03-14
K050078 — ROC LUMBAR PLATING SYSTEM2005-02-18
K042252 — NEXFLEX TOTAL HIP SYSTEM2004-12-06

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.