FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
SDS Growing Rod
K Number: K251961
·
Decision Jan 15, 2026
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
13
Applicant Total
5
Review Days
203
Basic Information
- Device Name
- SDS Growing Rod
- K Number
- K251961
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAAT Medical Products B.V.
- Date Received
- June 26, 2025
- Decision Date
- January 15, 2026
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PGM), ordered by most recent decision date.
VerteGlide Spinal Growth Guidance System
FDA 510(k)
FDA Class 2
·Orthopedic
MARVEL Growing Rods
FDA 510(k)
FDA Class 2
·Orthopedic
Daytona® Small Stature Growth Rod Conversion Set
FDA 510(k)
FDA Class 2
·Orthopedic
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
CREO® Stabilization System, REVERE® Stabilization System
FDA 510(k)
FDA Class 2
·Orthopedic
Polaris Spinal Growth System
FDA 510(k)
FDA Class 2
·Orthopedic