PMA P790002S023

Device: EBI BONE HEALING SYSTEM
Applicant: Ahp Eos Buyer, Inc.
PMA number: P790002
Supplement: S023
Product code: LOF
Decision date: 2005-09-26
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR THREE NEW COILS: THE FLX 5, THE XL COILETTE AND THE MINI COILETTE AND A MODIFIED VERSION OF THE BONE HEALING SYSTEM MODEL 2001 CONTROLLER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EBI BONE HEALING SYSTEM AND IS INDICATED FOR THE TREATMENT OF FRACTURE NON-UNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDOARTHROSES IN THE APPENDICULAR SYSTEM.

Current openFDA PMA Record#

Device: EBI BONE HEALING SYSTEM
Applicant: Ahp Eos Buyer, Inc.
PMA number: P790002
Supplement: S023
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2005-09-26
Decision code: APPR
Date received: 2005-06-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THREE NEW COILS: THE FLX 5, THE XL COILETTE AND THE MINI COILETTE AND A MODIFIED VERSION OF THE BONE HEALING SYSTEM MODEL 2001 CONTROLLER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EBI BONE HEALING SYSTEM AND IS INDICATED FOR THE TREATMENT OF FRACTURE NON-UNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDOARTHROSES IN THE APPENDICULAR SYSTEM.