VSP Cranial System
510(k) K151285
VSP Cranial System is a medical device (FDA Class II; FDA product code PPT, Cranial Surgical Planning And Instrument Guides) made by 3D Systems, Inc., cleared under FDA 510(k) K151285 on 23 Sep 2016, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151285 | Date23 Sep 2016 | StatusActive |
Official records
- FDA 510(k) database K151285
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PPT
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4310
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K151285
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VSP Cranial Cranial Cutting Guide | Cranial Cutting Guide | 00816847021432 | — | On the market |
| VSP Cranial Cranial Marking Guide | Cranial Marking Guide | 00816847021449 | — | On the market |
| VSP Cranial Cranial Positioning Guide | Cranial Positioning Guide | 00816847021425 | — | On the market |
| VSP System, VSP Cranial Bone Graft Template | Bone Graft Template | 00816847021272 | — | On the market |
| VSP System, VSP Cranial Bone Osteotomy Guide | Bone Osteotomy Guide | 00816847020961 | — | On the market |
| VSP System, VSP Cranial Bone Osteotomy Marking Guide | Bone Osteotomy Marking Guide | 00816847020954 | — | On the market |
| VSP System, VSP Cranial Bone Osteotomy Template | Bone Osteotomy Template | 00816847020947 | — | On the market |
| VSP System, VSP Cranial Bone Positioning Wedge | Bone Positioning Wedge | 00816847020725 | — | On the market |
| VSP System, VSP Cranial Bone Repositioning Guide | Bone Repositioning Guide | 00816847020749 | — | On the market |
| VSP System, VSP Cranial Distractor Drilling Guide | Distractor Drilling Guide | 00816847020718 | — | On the market |
| VSP System, VSP Cranial Distractor Marking Guide | Distractor Marking Guide | 00816847020701 | — | On the market |
| VSP System, VSP Cranial Full Skull Model | Full Skull Model | 00816847021029 | — | On the market |
| VSP System, VSP Cranial Graft Pre-Contouring Template | Graft Pre-Contouring Template | 00816847021265 | — | On the market |
| VSP System, VSP Cranial Implant Template | Implant Template | 00816847021289 | — | On the market |
| VSP System, VSP Cranial Mirrored Anatomical Model | Mirrored Anatomical Model | 00816847021173 | — | On the market |
| VSP System, VSP Cranial Original Anatomical Model | Original Anatomical Model | 00816847020992 | — | On the market |
| VSP System, VSP Cranial Perfected Anatomical Model | Perfected Anatomical Model | 00816847021180 | — | On the market |
| VSP System, VSP Cranial Perfected Full Skull Model | Perfected Full Skull Model | 00816847021210 | — | On the market |
| VSP System, VSP Cranial Reconstructed Anatomical Model | Reconstructed Anatomical Model | 00816847021050 | — | On the market |
| VSP System, VSP Cranial Reconstructed Full Skull Model | Reconstructed Full Skull Model | 00816847021081 | — | On the market |
| VSP System, VSP Cranial Repositioned Anatomical Model | Repositioned Anatomical Model | 00816847021111 | — | On the market |
| VSP System, VSP Cranial Repositioned Full Skull Model | Repositioned Full Skull Model | 00816847021142 | — | On the market |
| VSP System, VSP Cranial Resected Anatomical Model | Resected Anatomical Model | 00816847021463 | — | On the market |
| VSP System, VSP Cranial Resected Full Skull Model | Resected Full Skull Model | 00816847021456 | — | On the market |
| VSP System, VSP Cranial Resection Guide | Resection Guide | 00816847020930 | — | On the market |
| VSP System, VSP Cranial Surgical Positioning Guide | Surgical Positioning Guide | 00816847020763 | — | On the market |
| VSP System, VSP Cranial Surgical Positioning Template | Surgical Positioning Template | 00816847020756 | — | On the market |
| VSP System, VSP Cranial Trauma Drilling Guide | Trauma Drilling Guide | 00816847020688 | — | On the market |
| VSP System, VSP Cranial Trauma Positioning Guide | Trauma Positioning Guide | 00816847020695 | — | On the market |