FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Guided Growth Plate System Plus
K Number: K180624
·
Decision May 15, 2018
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
5
Applicant Total
38
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Guided Growth Plate System Plus
- K Number
- K180624
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthofix Srl
- Date Received
- March 9, 2018
- Decision Date
- May 15, 2018
- Product Code
- OBT
- 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 |
|---|---|---|---|
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OBT), ordered by most recent decision date.
The GIRO Growth Modulation System
FDA 510(k)
FDA Class 2
·Orthopedic
WishBone Guided Growth System
FDA 510(k)
FDA Class 2
·Orthopedic
Guided Growth Plate System Plus
FDA 510(k)
FDA Class 2
·Orthopedic
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
FDA 510(k)
FDA Class 2
·Orthopedic
GUIDED GROWTH SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Orthofix Srl
| K Number | Device Name | ||
|---|---|---|---|
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | May 19, 2026 | Substantially Equivalent |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | May 8, 2026 | Substantially Equivalent |
| K250112 | FitboneTM Trochanteric | Apr 10, 2025 | Substantially Equivalent |
| K242270 | OrthoNext Platform System | Dec 19, 2024 | Substantially Equivalent |
| K242861 | TrueLok Elevate | Dec 3, 2024 | Substantially Equivalent |
| K233867 | Fitbone Trochanteric | Jun 18, 2024 | Substantially Equivalent |
| K232648 | RODEO Telescopic Nail | May 3, 2024 | Substantially Equivalent |
| K232169 | FITBONE® Transport and Lengthening System | Mar 22, 2024 | Substantially Equivalent |
| K213572 | JuniOrtho Plating System | Jan 18, 2022 | Substantially Equivalent |
| K212044 | TrueLok Evo | Nov 5, 2021 | Substantially Equivalent |