CD HORIZON Growth Rod Conversion Set
FDA 510(k) K150200 · Medtronic Sofamor Danek USA, Incorporated
510(k) numberK150200
Submission
- Device name
- CD HORIZON Growth Rod Conversion Set
- Applicant
- Medtronic Sofamor Danek USA, Incorporated
Memphis, TN, US - Received
- January 29, 2015
- Decision date
- February 25, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K142114 | Xia® Growth Rod Conversion SetPGM · Traditional | Stryker Corporation | 10/27/2014SE |
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Questions and answers
When was CD HORIZON Growth Rod Conversion Set cleared by the FDA?
CD HORIZON Growth Rod Conversion Set (K150200) received a 510(k) decision of Substantially Equivalent on February 25, 2015, 27 days after the submission was received.
What is the product code of K150200?
The FDA product code is PGM – Growing Rod System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.