510(k) K220190
K220190 is an FDA 510(k) premarket notification submitted by Pega Medical, Inc. for the device "The GIRO Growth Modulation System". The FDA issued a decision of Substantially Equivalent on October 24, 2022. The device falls under product code OBT (Plate, Bone, Growth Control, Pediatric, Epiphysiodesis), a Class II device regulated under 21 CFR 888.3030. Pega Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 2022
- Date Received
- January 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
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.