FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VSP Orthopedics System
K Number: K250711
·
Decision Dec 5, 2025
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
26
Applicant Total
12
Review Days
270
Basic Information
- Device Name
- VSP Orthopedics System
- K Number
- K250711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D Systems, Inc.
- Date Received
- March 10, 2025
- Decision Date
- December 5, 2025
- Product Code
- PBF
- 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 |
|---|---|---|---|
| PBF | Orthopaedic Surgical Planning And Instrument Guides | FDA class 2 | Orthopedic |
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Other Clearances by 3D Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint) | Jun 3, 2026 | 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 |
| K231834 | VSP PEEK Cranial Implant | Apr 4, 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 |