Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
- US Product Code (FDA)
- OBTView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 888.3030View CFR Regulation →
- Medical specialty
- Orthopedic
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- Yes
- Third party review
- Not Eligible
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.
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Plate, Bone, Growth Control, Pediatric, Epiphysiodesis is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products. This device type includes life-sustaining products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.