OBT · Class II · 21 CFR 888.3030

FDA Product Code OBT: Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

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.

6
Total
6
Cleared
182d
Avg days
2010
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Devices (Product Code OBT)

6 devices
1–6 of 6
No devices found for this product code.

About Product Code OBT - Regulatory Context

510(k) Submission Activity

6 total 510(k) submissions under product code OBT since 2010, with 6 receiving FDA clearance (average review time: 182 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.