Solera
Driver NAV2022K Solera 5.5/6 FAS/SAS LG2
5manufacturers in China registered for this device type
25catalogue 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) | K140454 |
| Record published | 2016-08-29 |
| Record revised | 2018-10-05 (version 5) |
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 to 10.5 mm; width 4.5 to 6.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NAV2001K | Outer Diameter 4.0 mm | In distribution |
| NAV2004K | Outer Diameter 5.5 mm | In distribution |
| NAV2009K | Outer Diameter 8.0 mm | In distribution |
| NAV2023K | Outer Diameter 4.75 mm | In distribution |
| NAV2021K | Width 6.0 mm | In distribution |
| NAV2006K | Outer Diameter 6.5 mm | In distribution |
| NAV2018K | In distribution | |
| NAV2007K | Outer Diameter 7.0 mm | In distribution |
| NAV2022K | Width 5.5 mm | In distribution |
| NAV2014K | Outer Diameter 10.5 mm | In distribution |
| NAV2015K | Width 4.5 mm | In distribution |
| NAV2016K | Width 5.5 mm | In distribution |
| NAV2002K | Outer Diameter 4.5 mm | In distribution |
| NAV2017K | In distribution | |
| NAV2025K | Outer Diameter 4.75 mm | In distribution |
| NAV2005K | Outer Diameter 6.0 mm | In distribution |
| NAV2010K | Outer Diameter 8.5 mm | In distribution |
| NAV2012K | Outer Diameter 9.5 mm | In distribution |
| NAV2013K | Outer Diameter 10.0 mm | In distribution |
| NAV2024K | Outer Diameter 4.75 mm | In distribution |
| NAV2008K | Outer Diameter 7.5 mm | In distribution |
| NAV2003K | Outer Diameter 5.0 mm | In distribution |
| NAV2019K | Width 6.0 mm | In distribution |
| NAV2011K | Outer Diameter 9.0 mm | In distribution |
| NAV2020K | Width 5.5 mm | 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.