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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceOSTEOSPACE
Generic NameBone sonometer
Regulation Number892.1180
ApplicantMEDILINK
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 
Docket Number 05M-0024
Notice Date 01/21/2005
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  
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