OrthoPediatrics PediNail Intramedullary Platform
FDA 510(k) K172583 · Orthopediatrics, Inc.
510(k) numberK172583
Submission
- Device name
- OrthoPediatrics PediNail Intramedullary Platform
- Applicant
- Orthopediatrics, Inc.
Warsaw, IN, US - Received
- August 28, 2017
- Decision date
- May 10, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate SystemHRS · Traditional | 04/30/2026SE |
| K252600 | Pediatric Plating Platform I Small-MiniHRS · Traditional | 10/09/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | 06/24/2025SE |
| K243963 | Pediatric Plating Platform HipHRS · Traditional | 04/29/2025SE |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurHSB · Special | 04/01/2025SE |
| K241816 | VerteGlide Spinal Growth Guidance SystemPGM · Traditional | 03/14/2025SE |
| K243798 | Orthex External Fixation SystemKTT · Traditional | 03/07/2025SE |
| K233105 | RESPONSE Rib and Pelvic SystemMDI · Traditional | 01/20/2024SE |
| K231266 | Pediatric Nailing Platform TibiaHSB · Traditional | 08/21/2023SE |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw SystemNKB · Special | 03/23/2023SE |
Questions and answers
When was OrthoPediatrics PediNail Intramedullary Platform cleared by the FDA?
OrthoPediatrics PediNail Intramedullary Platform (K172583) received a 510(k) decision of Substantially Equivalent on May 10, 2018, 255 days after the submission was received.
What is the product code of K172583?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.