OSTEOSPACE
FDA premarket approval P010058 · decided 2004-03-15
Approval details
- PMA number
- P010058
- Trade name
- OSTEOSPACE
- Generic name
- Bone sonometer
- Applicant
- Medilink
- Date received
- 2001-10-03
- Decision date
- 2004-03-15
- Days to decision
- 894 days
- Decision code
- APRL
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Carnon
- 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.
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