Stimulator, Bone Growth, Non-Invasive
Basic Information
- Device Name
- Stimulator, Bone Growth, Non-Invasive
- Trade Name
- BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR
- PMA Number
- P850022
- Supplement Number
- S015
- Device Class
- FDA Class 3
- Product Code
- LOF
- Generic Name
- Stimulator, bone growth, non-invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 12, 2004
- Date Received
- September 30, 2003
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MODIFIED VERSION OF THE BIOELECTRON SPINALPAK FUSION STIMULATOR. THE MODIFICATIONS ARE: 1) THE CURRENT SPINALPAK IS POWERED BY 1 ALKALINE 9 VOLT BATTERY THAT MUST BE REPLACED DAILY. THE MODIFIED VERSION WILL BE POWERED BY 1 NIMN "AA" RECHARGEABLE CELL. THE CHARGER WILL BE INCLUDED. 2) THE HOUSING HAS BEEN MODIFIED TO ACCOMMODATE FOR A RECHARGEABLE BATTERY AND AN LCD DISPLAY. THE CURRENT SPINALPAK HAS AN LED DISPLAY. THE MODIFIED VERSION WILL HAVE A 6 MESSAGE LCD DISPLAY. 3) THE PCB CIRCUITRY HAS BEEN MODIFIED TO ACCOMMODATE THE LCD DISPLAY AND THE RECHARGEABLE BATTERY PACK. 4) THE ORIGINAL SOFTWARE WAS WRITTEN IN ASSEMBLY CODE. THE MODIFIED VERSION WAS REWRITTEN IN C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR AND IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
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 |
|---|---|---|---|
| LOF | Stimulator, Bone Growth, Non-Invasive | FDA class 3 | Unknown |