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Osteospace Bone Sonometer

by Medilink

PMA P010058

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P010058↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP010058 Date15 Mar 2004DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Osteospace
Generic Name
Bone sonometer
PMA Number
FDA Product Code
MUA
Device Class
Class II
Regulation
21 CFR Part 892.1180
Advisory Committee
Radiology
FDA Decision
APRL

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Osteospace is a Quantitative Ultrasound Bone Sonometer Device (QUS) classified as a Bone Sonometer. It measures Broadband Ultrasound Attenuation (BUA) of the calcaneus to assess bone strength and diagnose osteoporosis or related conditions that reduce skeletal integrity. The device provides quantitative output in BUA, T-score, and Z-score to aid clinical risk assessment for subsequent atraumatic fractures.

The Osteospace is supplied as a Class II medical device under FDA PMA approval (PMA Number: P010058) and is intended for use in radiology settings. It is not specified as single-use or reusable, though its regulatory classification and intended diagnostic application imply clinical use in controlled environments. No details regarding MRI safety or sterility are provided in the specifications.