Orthopedic Stereotaxic Instrument
Driver 6550006 5.5/6.0 SV SET Screw Drvr
5manufacturers in China registered for this device type
44catalogue numbers in this listing
1510(k) clearance
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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| 510(k) | K161210 |
| Record published | 2019-03-02 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 4.75 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7429001 | In distribution | |
| 9735468 | In distribution | |
| NAV2142 | 13mm | In distribution |
| 6550006 | In distribution | |
| NAV3650014 | In distribution | |
| NAV3650013 | In distribution | |
| 9735286 | In distribution | |
| 9735468 | In distribution | |
| NAV3656044 | In distribution | |
| NAV2079K | In distribution | |
| NAV2081K | In distribution | |
| NAV2141 | In distribution | |
| NAV2080K | In distribution | |
| 9735286 | In distribution | |
| NAV2139 | In distribution | |
| NAV2028K | In distribution | |
| NAV2024K | Outer Diameter 4.75 mm | In distribution |
| NAV2137 | 7mm | In distribution |
| NAV2077K | In distribution | |
| NAV3650015 | In distribution | |
| NAV3656050 | In distribution | |
| 9735123 | In distribution | |
| NAV3650010 | In distribution | |
| RBT090002 | In distribution | |
| NAV2082K | In distribution | |
| NAV3650011 | In distribution | |
| RBT090006 | In distribution | |
| 9735278 | In distribution | |
| NAV3650012 | In distribution | |
| 9735123 | In distribution | |
| RBT090001 | In distribution | |
| NAV2137 | In distribution | |
| 9735278 | In distribution | |
| NAV2139 | In distribution | |
| 9735288 | In distribution | |
| NAV2076K | In distribution | |
| NAV2142 | 13mm | In distribution |
| NAV2026K | In distribution | |
| NAV2027K | In distribution | |
| NAV2137 | 7mm | In distribution |
| 6550021 | In distribution | |
| RBT090005 | In distribution | |
| NAV2078K | In distribution | |
| NAV3656060 | 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 |
|---|---|
| K230716 | 2023-07-18 |
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 |
|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-07-12 | Class II | Under Investigation by firm | Incorrect Laser Marking – Solera Awl Tip Tap | 13 devices |
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.