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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceOSTEOSPACE
Classification Namebone sonometer
Generic Namebone sonometer
Regulation Number892.1180
Applicant
MEDILINK
80, rue de l'hortus
carnon F3428
PMA NumberP010058
Date Received10/03/2001
Decision Date03/15/2004
Reclassified Date 08/18/2008
Product Code
MUA[ Registered Establishments with MUA ]
Docket Number 05M-0024
Notice Date 01/21/2005
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the osteospace. The osteospace is a quantitative ultrasound bone sonometer device (qus) to be used for the measurement of broadband ultrasound attenuation (bua) of the calcaneus, as an aid, together with other clinical risk factors, to diagnose osteoporosis and other medical conditions leading to reduced bone strength and to estimate the risk of subsequent atraumatic fracture. The output is expressed in terms of bua, t-score, and z-score.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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