|
Device | OSTEOSPACE |
Generic Name | Bone sonometer |
Regulation Number | 892.1180 |
Applicant | MEDILINK 80, RUE DE L'HORTUS CARNON F3428 |
PMA Number | P010058 |
Date Received | 10/03/2001 |
Decision Date | 03/15/2004 |
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 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 |
Supplements: |
|
|
|