510(k) K213196
K213196 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "MARVEL Growing Rods". The FDA issued a decision of Substantially Equivalent on December 19, 2022. The device falls under product code PGM (Growing Rod System), a Class II device regulated under 21 CFR 888.3070. Globus Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2022
- Date Received
- September 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Growing Rod System
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
Stabilization or correction of spinal deformities without the use of fusion.