Daytona® Small Stature Growth Rod Conversion Set
FDA 510(k) K193224 · SeaSpine Orthopedics Corporation
510(k) numberK193224
Submission
- Device name
- Daytona® Small Stature Growth Rod Conversion Set
- Applicant
- SeaSpine Orthopedics Corporation
Carlsbad, CA, US - Received
- November 22, 2019
- Decision date
- February 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGM – Growing Rod System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Stabilization or correction of spinal deformities without the use of fusion.
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|---|---|---|---|
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| K180227 | Polaris Spinal Growth SystemPGM · Traditional | Zimmer Biomet Spine, Inc. | 03/15/2018SE |
| K172979 | NuVasive® Growth Rod Conversion SetPGM · Traditional | Nu Vasive, Incorporated | 11/06/2017SE |
| K161028 | K2M Growing Spine SystemPGM · Traditional | K2m, Inc. | 07/22/2016SE |
| K150200 | CD HORIZON Growth Rod Conversion SetPGM · Special | Medtronic Sofamor Danek USA, Incorporated | 02/25/2015SE |
| K142114 | Xia® Growth Rod Conversion SetPGM · Traditional | Stryker Corporation | 10/27/2014SE |
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Questions and answers
When was Daytona® Small Stature Growth Rod Conversion Set cleared by the FDA?
Daytona® Small Stature Growth Rod Conversion Set (K193224) received a 510(k) decision of Substantially Equivalent on February 13, 2020, 83 days after the submission was received.
What is the product code of K193224?
The FDA product code is PGM – Growing Rod System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.