PMA P910066S011
- Device
- ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
- Applicant
- Djo, LLC
- PMA number
- P910066
- Supplement
- S011
- Product code
- LOF
- Decision date
- 1999-12-17
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Change to the indications for use and will be marked under the tradename SpinaLogic.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P910066S011B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
- Applicant
- Djo, LLC
- PMA number
- P910066
- Supplement
- S011
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 1999-12-17
- Decision code
- APPR
- Date received
- 1998-08-20
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Change to the indications for use and will be marked under the tradename SpinaLogic.