AccelStimTM Bone Growth Stimulator

FDA Premarket Approval P210035

Pre-market Approval Supplement Details

DeviceAccelStimTM Bone Growth Stimulator
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantOrthofix US LLC3451 Plano Parkwaylewisville, TX 75056 PMA NumberP210035 Date Received10/13/2021 Decision Date05/03/2022 Product Code LOF  Advisory Committee Orthopedic Expedited Review Granted? No
Date Received2021-10-13
Decision Date2022-05-03
PMAP210035
SupplementS
Product CodeLOF 
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination ProductNo
Applicant AddressOrthofix US LLC
3451 Plano Parkway
lewisville, TX 75056 PMA NumberP210035 Date Received10/13/2021 Decision Date05/03/2022 Product Code LOF  Advisory Committee Orthopedic Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For The AccelStim Ultrasound Bone Growth Stimulator, A Non-invasive Low-Intensity Pulsed Ultrasound (LIPUS) Device Intended To Aid Fracture Healing. The Device Is Rx Only, And Intended For Single Patient Use In Adult Patients Only. Approval OrderApproval Order SummarySummary Of Safety And Effectiveness LabelingLabeling
Supplements:  

Supplemental Filings

A PHP Error was encountered

Severity: Notice

Message: Undefined offset: 0

Filename: fda.report/pma_item.php

Line Number: 133

Backtrace:

File: /var/www/fda.report/pma_item.php
Line: 133
Function: _error_handler

Supplement NumberDateSupplement Type
P210035Original Filing

NIH GUDID Devices

Device IDPMASupp
08050040997213 P210035 000
08050040997329 P210035 000
08050040997312 P210035 000
08050040997305 P210035 000
08050040997299 P210035 000
08050040997336 P210035 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.