LogoFDA 510(k) Search
K Number
K003155

Validate with FDA (Live)

Device Name
VERTEBRAL BODY REPLACEMENT
Manufacturer
OSTEOTECH, INC.
Date Cleared
2001-01-04

(86 days)

Product Code
MQP
Regulation Number
888.3060
Type
Traditional
Panel
Orthopedic
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K012254,K041798,K050058,K070181,K070786,K181921
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

N/A