PMA P910066S012

Device: ORTHOLOGIC 1000 SC
Applicant: Djo, LLC
PMA number: P910066
Supplement: S012
Product code: LOF
Decision date: 1998-10-16
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Modifications to the sizes of the device. The device, as modified, will be marketed under the trade name Orthologic 1000-SC and is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Current openFDA PMA Record#

Device: ORTHOLOGIC 1000 SC
Applicant: Djo, LLC
PMA number: P910066
Supplement: S012
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 1998-10-16
Decision code: APPR
Date received: 1998-09-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Modifications to the sizes of the device. The device, as modified, will be marketed under the trade name Orthologic 1000-SC and is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.