Curiteva Navigation System
Curiteva Navigation System is a reusable instrument range for preparing for and placing Curiteva spinal screws with surgical navigation. Awls, probes, taps, drills and drivers perform the…
Curiteva Navigation System is a reusable instrument range for preparing for and placing Curiteva spinal screws with surgical navigation. Awls, probes, taps, drills and drivers perform the mechanical preparation and placement tasks.
The stainless steel instruments work with Medtronic StealthStation S7 version 2.1.0 or S8 version 1.2.0. The navigation setup relates the tools and anatomy to a CT or MR model, fluoroscopy images or digitized landmarks.
Listed Item
Extended Tab Pedicle Screw Driver, Navigation, Prodigy
Implant Compatibility
The instruments are specified for the Curiteva Pedicle Screw System or Curiteva Sacroiliac Joint Fusion System. An extended-tab driver is one tool configuration in the range; the stated compatibility is limited to the Curiteva implants and named navigation platform.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Curiteva, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K223200 |
| Record published | 2023-09-19 |
| Record revised | 2023-12-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 4.5 to 6.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C645-100 | In distribution | |
| C595-310-75 | In distribution | |
| C595-310-45 | In distribution | |
| C645-221 | In distribution | |
| C595-400 | In distribution | |
| C595-310-95 | In distribution | |
| C595-300-45 | In distribution | |
| C595-300-65 | In distribution | |
| C645-400 | In distribution | |
| C645-410 | In distribution | |
| C595-305-55 | Outer Diameter 5.5 mm | In distribution |
| C595-310-65 | In distribution | |
| C595-200 | In distribution | |
| C645-310 | In distribution | |
| C645-220 | In distribution | |
| C645-201 | In distribution | |
| C645-200 | In distribution | |
| C645-300 | In distribution | |
| C595-300-75 | In distribution | |
| C595-305-65 | Outer Diameter 6.5 mm | In distribution |
| C595-100 | In distribution | |
| C595-310-85 | In distribution | |
| C595-300-105 | In distribution | |
| C595-300-55 | In distribution | |
| C595-300-95 | In distribution | |
| C645-411 | In distribution | |
| C645-301 | In distribution | |
| C645-311 | In distribution | |
| C645-210 | In distribution | |
| C595-305-45 | Outer Diameter 4.5 mm | In distribution |
| C595-110 | In distribution | |
| C645-320 | In distribution | |
| C645-401 | In distribution | |
| C595-300-85 | In distribution | |
| C645-321 | In distribution | |
| C595-401 | In distribution | |
| C595-310-105 | In distribution | |
| C595-310-55 | In distribution | |
| C645-211 | In distribution | |
| C595-210 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223200 | 2023-01-06 |
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.