MARVEL Growing Rods
FDA 510(k) K213196 · Globus Medical, Inc.
510(k) numberK213196
Submission
- Device name
- MARVEL Growing Rods
- Applicant
- Globus Medical, Inc.
Audubon, PA, US - Received
- September 29, 2021
- Decision date
- December 19, 2022
- 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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Questions and answers
When was MARVEL Growing Rods cleared by the FDA?
MARVEL Growing Rods (K213196) received a 510(k) decision of Substantially Equivalent on December 19, 2022, 446 days after the submission was received.
What is the product code of K213196?
The FDA product code is PGM – Growing Rod System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.