Product code OBT

Device name
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3030
Review panel
OR
Implant
Y
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius). The device may be removed when growth has equalized or the growth plate has fused.
Source
FDA openFDA device classification dataset