VSP System Surgical Splint
VSP System Surgical Splint is a medical device (FDA Class II) made by 3D Systems, Inc., cleared under FDA 510(k) K192192 on 26 Feb 2020 (2 earlier submissions) and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00816847020510), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192192 | Date26 Feb 2020 | StatusActive |
| United States | GUDID listing | Number00816847020510 | Date12 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00816847020510
- FDA 510(k) database K192192
- FDA 510(k) database K133907
- FDA 510(k) database K120956
Across registries
- FDA 510(k) K192192 decided 26 Feb 2020 Active
- FDA GUDID UDI-DI 00816847020510 listed 12 Sep 2016 Listed
Recalls
-
- Ongoing Z-1510-2022
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Timeline
- Cleared FDA 510(k) K120956
- Cleared FDA 510(k) K133907
- Listed FDA GUDID 00816847020510
- Cleared FDA 510(k) K192192
- Recall initiated FDA recalls Z-1510-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VSP System
- Generic name
- Custom-made orthopaedic/craniofacial surgical guide
- Model / reference
- Surgical Splint
- Primary DI / UDI-DI
- 00816847020510
- FDA product code
- LLZ, DZJ
- GMDN term
- Custom-made orthopaedic/craniofacial surgical guide
- Device class
- Class II
- Regulation number
- 892.2050, 872.4120
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Unsafe
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