Guided Growth Plate System Plus
FDA 510(k) K172183 · Orthofix Srl
510(k) numberK172183
Submission
- Device name
- Guided Growth Plate System Plus
- Applicant
- Orthofix Srl
Bussolengo, IT - Received
- July 19, 2017
- Decision date
- January 9, 2018
- 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)…
Other 510(k)s with product code OBT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220190 | The GIRO Growth Modulation SystemOBT · Traditional | Pega Medical, Inc. | 10/24/2022SE |
| K182704 | WishBone Guided Growth SystemOBT · Traditional | Wishbone Medical | 06/25/2019SE |
| K180624 | Guided Growth Plate System PlusOBT · Special | Orthofix Srl | 05/15/2018SE |
| K110805 | Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)OBT · Special | Orthofix, Inc. | 06/21/2011SE |
| K093442 | Guided Growth SystemOBT · Special | Orthofix, Inc. | 06/10/2010SE |
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Questions and answers
When was Guided Growth Plate System Plus cleared by the FDA?
Guided Growth Plate System Plus (K172183) received a 510(k) decision of Substantially Equivalent on January 9, 2018, 174 days after the submission was received.
What is the product code of K172183?
The FDA product code is OBT – Plate, Bone, Growth Control, Pediatric, Epiphysiodesis, a Class II (moderate risk) device regulated under 21 CFR 888.3030.