Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K133907
VSP SYSTEM · Medical Modeling, Inc. · decided 2014-01-22 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VSP System | Scapula Cutting Guide | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020879 |
| VSP System | LeFort Marking Guide | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020596 |
| VSP System, VSP Cranial | Bone Osteotomy Marking Guide | 3D SYSTEMS, INC. | DZJ LLZ PPT | 00816847020954 |
| VSP System | Mandible Cutting Guide | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020817 |
| VSP System | Repositioned Maxilla/Mandible 2-Piece Model | 3D SYSTEMS, INC. | DZJ LLZ | 00816847021166 |
| VSP System, VSP Cranial | Reconstructed Anatomical Model | 3D SYSTEMS, INC. | DZJ LLZ PPT | 00816847021050 |
| VSP System | Sagittal Split Marking Guide with Predictive Hole Placement | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020640 |
| VSP System, VSP Cranial | Distractor Drilling Guide | 3D SYSTEMS, INC. | DZJ LLZ PPT | 00816847020718 |
| VSP System | Sagittal Split Marking Guide | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020633 |
| VSP System | Intermediate Sandwich Surgical Splint | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020558 |
| VSP System | Perfected Maxilla Model | 3D SYSTEMS, INC. | DZJ LLZ | 00816847021197 |
| VSP System | Iliac Crest Cutting Guide | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020855 |
| VSP System, VSP Cranial | Full Skull Model | 3D SYSTEMS, INC. | DZJ LLZ PPT | 00816847021029 |
| VSP System | LeFort Drilling Guide | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020572 |
| VSP System, VSP Cranial | Resected Anatomical Model | 3D SYSTEMS, INC. | DZJ LLZ PPT | 00816847021463 |
| VSP System | Repositioned Maxilla/Mandible 1-Piece Model | 3D SYSTEMS, INC. | DZJ LLZ | 00816847021159 |
| VSP System | Rib Cutting Guide | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020893 |
| VSP System | Genioplasty Marking Guide | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020671 |
| VSP System | Repositioned Mandible Model | 3D SYSTEMS, INC. | DZJ LLZ | 00816847021135 |
| VSP System | Maxilla/Mandible 1-Piece Model | 3D SYSTEMS, INC. | DZJ LLZ | 00816847021036 |
| VSP System, VSP Cranial | Trauma Positioning Guide | 3D SYSTEMS, INC. | DZJ LLZ PPT | 00816847020695 |
| VSP System, VSP Cranial | Reconstructed Full Skull Model | 3D SYSTEMS, INC. | DZJ LLZ PPT | 00816847021081 |
| VSP System | Fibula Cutting Guide | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020794 |
| VSP System, VSP Cranial | Repositioned Full Skull Model | 3D SYSTEMS, INC. | DZJ LLZ PPT | 00816847021142 |
| VSP System | Mandible Marking Guide | 3D SYSTEMS, INC. | DZJ LLZ | 00816847020824 |