Navigated Instrument System
Reform Ti CT Cannulated T25 Poly Driver, Stealth Navigation
5manufacturers in China registered for this device type
76catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Precision Spine, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K231229 |
| Record published | 2024-01-04 |
| Record revised | 2024-01-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2026-07-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 76-BK-0100 | In distribution | |
| 70-RT-1720 | In distribution | |
| 76-CR-0535 | In distribution | |
| 70-BK-0103 | In distribution | |
| 76-CR-0435 | In distribution | |
| 76-CR-0040 | In distribution | |
| 70-SC-0103 | In distribution | |
| 70-MC-0545 | In distribution | |
| 70-3L-0565 | In distribution | |
| 70-BK-0100 | In distribution | |
| 70-MC-0455 | In distribution | |
| 70-3L-0001 | In distribution | |
| 70-MC-1800 | In distribution | |
| 70-RH-1095 | In distribution | |
| 76-CR-0545 | In distribution | |
| 70-MC-0445 | In distribution | |
| 70-MC-0465 | In distribution | |
| 70-MC-0820 | In distribution | |
| 70-RT-1730 | In distribution | |
| 70-RF-0555 | In distribution | |
| 70-MC-0595 | In distribution | |
| 70-BK-0108 | In distribution | |
| 70-RT-0730 | In distribution | |
| 70-BK-0109 | In distribution | |
| 70-BK-0101 | In distribution | |
| 70-CT-0750 | In distribution | |
| 70-BK-0106 | In distribution | |
| 70-3L-0575 | In distribution | |
| 70-MC-0040 | In distribution | |
| 70-3L-0585 | In distribution | |
| 70-SC-0100 | In distribution | |
| 70-RF-0595 | In distribution | |
| 70-BK-0104 | In distribution | |
| 70-3L-0555 | In distribution | |
| 70-RH-1065 | In distribution | |
| 70-RF-0003 | In distribution | |
| 70-SC-0105 | In distribution | |
| 76-CR-0440 | In distribution | |
| 70-SC-0101 | In distribution | |
| 70-MC-0555 | In distribution | |
| 70-RH-1075 | In distribution | |
| 70-MC-0700 | In distribution | |
| 70-MD-2800 | In distribution | |
| 70-RF-0585 | In distribution | |
| 70-RH-1045 | In distribution | |
| 70-RF-0575 | In distribution | |
| 70-RT-0720 | In distribution | |
| 70-RH-1055 | In distribution | |
| 76-CR-0540 | In distribution | |
| 70-CT-0700 | In distribution | |
| 70-MC-0800 | In distribution | |
| 70-BK-0107 | In distribution | |
| 70-MC-0550 | In distribution | |
| 70-RF-0565 | In distribution | |
| 76-SC-0100 | In distribution | |
| 70-MC-0450 | In distribution | |
| 70-RF-0700 | In distribution | |
| 70-SC-0104 | In distribution | |
| 70-3L-0595 | In distribution | |
| 70-BK-0102 | In distribution | |
| 70-RF-0001 | In distribution | |
| 70-MC-1820 | In distribution | |
| 70-RT-1750 | In distribution | |
| 70-RF-0545 | In distribution | |
| 76-CR-0050 | In distribution | |
| 70-SC-0102 | In distribution | |
| 70-MC-0585 | In distribution | |
| 70-RM-0800 | In distribution | |
| 70-MC-0575 | In distribution | |
| 70-MC-0565 | In distribution | |
| 70-RH-1085 | In distribution | |
| 70-3L-0545 | In distribution | |
| 70-BK-0105 | In distribution | |
| 70-CT-1700 | In distribution | |
| 70-3L-0700 | In distribution | |
| 70-SP-2600 | Withdrawn |
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 |
|---|---|
| K231229 | 2023-05-25 |
| K220862 | 2022-07-14 |
| K181606 | 2019-09-27 |
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.