510(k) K241816
K241816 is an FDA 510(k) premarket notification submitted by OrthoPediatrics Corp. for the device "VerteGlide Spinal Growth Guidance System". The FDA issued a decision of Substantially Equivalent on March 14, 2025. The device falls under product code PGM (Growing Rod System), a Class II device regulated under 21 CFR 888.3070. OrthoPediatrics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2025
- Date Received
- June 24, 2024
- 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.