FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vertiwedge® Intraosseous System
K Number: K241468
·
Decision Nov 7, 2024
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
3
Review Days
167
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
- Vertiwedge® Intraosseous System
- K Number
- K241468
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Foundation Surgical Group, Inc.
- Date Received
- May 24, 2024
- Decision Date
- November 7, 2024
- Product Code
- MQP
- 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQP), ordered by most recent decision date.
VyBrate VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
KONG®-TL VBR System and KONG® C VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
DOMINION Expandable Corpectomy System
FDA 510(k)
FDA Class 2
·Orthopedic
VerteLoc Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Ascend VBR System, Ascend NanoTec VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
FDA 510(k)
FDA Class 2
·Orthopedic