FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VSP PEEK Cranial Implant
K Number: K231834
·
Decision Apr 4, 2024
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
12
Review Days
287
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
- VSP PEEK Cranial Implant
- K Number
- K231834
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D Systems, Inc.
- Date Received
- June 22, 2023
- Decision Date
- April 4, 2024
- Product Code
- GWO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWO), ordered by most recent decision date.
TECHFIT Patient-Specific Cranial System
FDA 510(k)
FDA Class 2
·Neurology
Fusion Craniofacial Implant; Fusion Skull Implant
FDA 510(k)
FDA Class 2
·Neurology
MCI-Neuro Fixation System
FDA 510(k)
FDA Class 2
·Neurology
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
FDA 510(k)
FDA Class 2
·Neurology
Stryker PEEK Customized Cranial Implant Kit
FDA 510(k)
FDA Class 2
·Neurology
Optimus NEURO System - Sterile Kit
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by 3D Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint) | Jun 3, 2026 | Substantially Equivalent |
| K250711 | VSP Orthopedics System | Dec 5, 2025 | Substantially Equivalent |
| K243173 | Salto Talaris Ankle PSI System | Oct 25, 2024 | Substantially Equivalent |
| K243174 | Cadence Ankle PSI System | Oct 25, 2024 | Substantially Equivalent |
| K241148 | Salto Talaris Ankle PSI System | Aug 30, 2024 | Substantially Equivalent |
| K241326 | Cadence Ankle PSI System | Aug 30, 2024 | Substantially Equivalent |
| K231585 | Vantage PSI System | Jun 30, 2023 | Substantially Equivalent |
| K183489 | D2P | Aug 29, 2019 | Substantially Equivalent |
| K190044 | VSP Orthopedics System | Aug 21, 2019 | Substantially Equivalent |
| K161841 | D2P | Jan 9, 2017 | Substantially Equivalent |