FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARVEL Growing Rods
K Number: K213196
·
Decision Dec 19, 2022
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
13
Applicant Total
172
Review Days
446
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Basic Information
- Device Name
- MARVEL Growing Rods
- K Number
- K213196
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- September 29, 2021
- Decision Date
- December 19, 2022
- 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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Other Clearances by Globus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | May 7, 2026 | Substantially Equivalent |
| K253401 | SCRIPT Implant System | Apr 29, 2026 | Substantially Equivalent |
| K261043 | AUTOBAHN Nailing System | Apr 24, 2026 | Substantially Equivalent |
| K252166 | RIB LINK Fixation System | Feb 26, 2026 | Substantially Equivalent |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | Dec 22, 2025 | Substantially Equivalent |
| K250599 | ExcelsiusGPS Instruments | Nov 5, 2025 | Substantially Equivalent |
| K251161 | ANTHEM® Fracture System | Aug 18, 2025 | Substantially Equivalent |
| K241525 | ExcelsiusXR | Jul 8, 2025 | Substantially Equivalent |
| K243456 | ONVOY Acetabular System | Jun 6, 2025 | Substantially Equivalent |
| K243814 | NuVasive Pulse System | Jan 10, 2025 | Substantially Equivalent |