The GIRO Growth Modulation System
FDA 510(k) K220190 · Pega Medical, Inc.
Submission
- Device name
- The GIRO Growth Modulation System
- Applicant
- Pega Medical, Inc.
Laval, CA - Received
- January 24, 2022
- Decision date
- October 24, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBT – Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
- Life-sustaining
- Yes
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)…
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Questions and answers
When was The GIRO Growth Modulation System cleared by the FDA?
The GIRO Growth Modulation System (K220190) received a 510(k) decision of Substantially Equivalent on October 24, 2022, 273 days after the submission was received.
What is the product code of K220190?
The FDA product code is OBT – Plate, Bone, Growth Control, Pediatric, Epiphysiodesis, a Class II (moderate risk) device regulated under 21 CFR 888.3030.