VSP System, VSP Cranial
A physical guide used to hold bone in a position dictated by the surgeon for a limited amount of time. Once the bone repositioning guide stabilizes the position of the patient’s bone; the…
A physical guide used to hold bone in a position dictated by the surgeon for a limited amount of time. Once the bone repositioning guide stabilizes the position of the patient’s bone; the surgeon can determine a permanent solution
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological
Record
| Listed by | 3D Systems, Inc., Israel |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| 510(k) | K120956 |
| Record published | 2016-09-12 |
| Record revised | 2024-08-20 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 25 to 40 mm; outer diameter 1 to 2 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Bone Repositioning Guide | In distribution | |
| Resected Anatomical Model | In distribution | |
| Bone Osteotomy Marking Guide | In distribution | |
| Distractor Marking Guide | In distribution | |
| Bone Graft Template | In distribution | |
| Metal Slot (25mm) | Length 25 mm | In distribution |
| Repositioned Anatomical Model | In distribution | |
| Trauma Drilling Guide | In distribution | |
| Bone Osteotomy Template | In distribution | |
| Metal Slot (40mm) | Length 40 mm | In distribution |
| Reconstructed Anatomical Model | In distribution | |
| Original Anatomical Model | In distribution | |
| Drill Guide (1mm Pre-Drill) | Outer Diameter 1.0 mm | In distribution |
| Mirrored Anatomical Model | In distribution | |
| Perfected Full Skull Model | In distribution | |
| Bone Positioning Wedge | In distribution | |
| Drill Guide (2.0 mm Screws) | Outer Diameter 2.0 mm | In distribution |
| Surgical Positioning Guide | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagegrid Radiology Viewer System | Candelis, Inc. | 173 |
| Tims System | Foresight Imaging, LLC | 159 |
| System, Image Processing, Radiological | Biomet Microfixation | 146 |
| RamSoft | Ramsoft, Inc. | 65 |
| Joints | Medstrat | 62 |
| OrthoView | Meridian Technique Ltd | 54 |
| IPS | KLS-Martin L.P. | 48 |
| NovaPACS | Novarad Corp. | 42 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 34 |
| DTX Studio™ Clinic | Nobel Biocare AB | 34 |
| Eaglesoft | Patterson Technology Center | 33 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183489 | 2019-08-29 |
| K161841 | 2017-01-09 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medical Modeling – A 3D Systems Company | 510(k) number | 2022-05-17 | Class II | Employee error | Scapula Marking Guide (anatomically Shaped) was incorrectly designed. | 1 unit |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.