StealthAiR™ Spine
SFW KIT 9736350 Stealthair Spine
5manufacturers in China registered for this device type
2catalogue numbers in this listing
12510(k) clearances naming this product code
14recalls on this 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 | Medtronic Navigation, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K201189 |
| Record published | 2020-08-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9736350 | In distribution | |
| 9736350 | 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 |
|---|---|
| K253381 | 2026-02-12 |
| K251282 | 2025-10-17 |
| K242464 | 2025-06-05 |
| K211442 | 2021-07-08 |
| K201327 | 2020-06-18 |
| K201189 | 2020-05-29 |
| K182104 | 2018-11-02 |
| K180816 | 2018-07-11 |
| K171267 | 2017-07-03 |
| K170011 | 2017-05-01 |
| K131425 | 2013-08-14 |
| K124004 | 2013-03-22 |
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 Navigation, Inc. | 510(k) number | 2024-08-22 | Class II | Software design | Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation – when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree | 1,801 systems |
Recalls
13 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-12-04 | Class II | Under Investigation by firm | Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. | 67,370 pins | |
| 2023-11-28 | Class II | Device Design | Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove. | 4,224 | |
| 2023-11-28 | Class II | Device Design | Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove. | 4,235 units | |
| 2019-12-05 | Class II | Device Design | There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s | 177 Systems | |
| 2019-08-28 | Class II | Employee error | Product was incorrectly assembled which could affect navigation accuracy of the device. | 1 unit | 2021-05-05 |
| 2018-12-06 | Class II | Device Design | Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure. | 1,297 percutaneous pin adapters | 2020-12-17 |
| 2017-06-29 | Class II | Device Design | Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient’s spinous process or leaving a component behind in the patient’s body following breakage. | 2,051 units total | 2023-07-24 |
| 2017-06-29 | Class II | Device Design | Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient’s spinous process or leaving a component behind in the patient’s body following breakage. | 2,051 units total | 2023-07-24 |
| 2017-06-29 | Class II | Device Design | Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient’s spinous process or leaving a component behind in the patient’s body following breakage. | 2051 units | 2023-07-24 |
| 2017-06-29 | Class II | Device Design | Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient’s spinous process or leaving a component behind in the patient’s body following breakage. | 2,051 units total | 2023-07-24 |
| 2017-06-29 | Class II | Device Design | Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient’s spinous process or leaving a component behind in the patient’s body following breakage. | 2,051 units total | 2023-07-24 |
| 2016-07-18 | Class II | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. | 27 in total | 2016-12-01 |
| 2015-09-14 | Class II | Labeling design | Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. | 2,346 | 2015-12-03 |
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.