FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VerteGlide Spinal Growth Guidance System
K Number: K241816
·
Decision Mar 14, 2025
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
13
Applicant Total
40
Review Days
263
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Basic Information
- Device Name
- VerteGlide Spinal Growth Guidance System
- K Number
- K241816
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OrthoPediatrics Corp.
- Date Received
- June 24, 2024
- Decision Date
- March 14, 2025
- Product Code
- PGM
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PGM | Growing Rod System | FDA class 2 | Orthopedic |
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