Xia® Growth Rod Conversion Set
FDA 510(k) K142114 · Stryker Corporation
510(k) numberK142114
Submission
- Device name
- Xia® Growth Rod Conversion Set
- Applicant
- Stryker Corporation
Allendale, NJ, US - Received
- August 4, 2014
- Decision date
- October 27, 2014
- 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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|---|---|---|---|
| K251961 | SDS Growing RodPGM · Traditional | BAAT Medical Products B.V. | 01/15/2026SE |
| K241816 | VerteGlide Spinal Growth Guidance SystemPGM · Traditional | OrthoPediatrics Corp. | 03/14/2025SE |
| K213196 | MARVEL Growing RodsPGM · Traditional | Globus Medical, Inc. | 12/19/2022SE |
| K193224 | Daytona® Small Stature Growth Rod Conversion SetPGM · Traditional | SeaSpine Orthopedics Corporation | 02/13/2020SE |
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| K181068 | CREO® Stabilization System, REVERE® Stabilization SystemPGM · Traditional | Globus Medical, Inc. | 06/29/2018SE |
| 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 |
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Questions and answers
When was Xia® Growth Rod Conversion Set cleared by the FDA?
Xia® Growth Rod Conversion Set (K142114) received a 510(k) decision of Substantially Equivalent on October 27, 2014, 84 days after the submission was received.
What is the product code of K142114?
The FDA product code is PGM – Growing Rod System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.