SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device— 510(k) K173606

Substantially Equivalent

SeaSpine Orthopedics Corporation

FDA 510(k) clearance K173606 for SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device, Substantially Equivalent on 2018-04-13. Applicant: SeaSpine Orthopedics Corporation. Device class: 2.

Clearance details

Applicant
SeaSpine Orthopedics Corporation
Product code
Code OVD
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OVD

product code OVD
Death
5
Injury
495
Total
500

Source: openFDA MAUDE database, through . 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.