Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Basic Information
- Device Name
- Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
- Trade Name
- EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R))
- PMA Number
- P900009
- Supplement Number
- S013
- Device Class
- FDA Class 3
- Product Code
- LPQ
- Generic Name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 4, 2001
- Date Received
- April 30, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE LOW INTENSITY ULTRASOUND FRACTURE TREATMENT SYSTEM-SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) AND IS INDICATED FOR THE NON-INVASIVE TREATMENT OF ESTBLISHED NONUNIONS* EXLUDING SKULL AND VERTEBRA. IN ADDITION, THE EXOGEN 2000+(TM) OR SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) IS INDICATED FOR ACCELERATING THE TIME TO A HEALED FRACTURE FOR FRESH, CLOSED, POSTERIORLY DISPLACED DISTAL RADIUS FRACTURES AND FRESH, CLOSED OR GRADE 1 OPEN TIBIAL DIAPHYSIS IN SKELETALLY MATURE INDIVIDUALS WHEN THESE FRACTURES ARE ORTHOPEDICALLY MANAGED BY CLOSED REDUCTION AND CAST IMMOBILIZATION. * A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLY PROGRESSIVE SIGNS OF HEALING.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPQ | Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep | FDA class 3 | Unknown |