Orthopedic Stereotaxic Instrument
Inst KIT 9735281 Driver 5.5/6.0 MAS Ncan
5manufacturers in China registered for this device type
356catalogue 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) | K211442 |
| Record published | 2018-11-15 |
| Record revised | 2023-04-04 (version 6) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Outer diameter 3.75 to 8.5 mm; length 100 to 150 mm |
| Distribution end date | 2019-08-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 961-574 | In distribution | |
| 9734664 | In distribution | |
| 9734723K | In distribution | |
| 9734494 | In distribution | |
| 9735265 | In distribution | |
| 9735023 | In distribution | |
| 9733816 | In distribution | |
| 9734958 | In distribution | |
| 9734567 | 14X26mm | In distribution |
| 9735108 | In distribution | |
| 9735266 | In distribution | |
| 9735607 | In distribution | |
| 9734724K | In distribution | |
| 9735205 | In distribution | |
| 9734494 | In distribution | |
| 9735142 | In distribution | |
| 961-574 | In distribution | |
| 9735270 | In distribution | |
| 9734259 | In distribution | |
| 9733817 | In distribution | |
| 9734296 | In distribution | |
| 9734489 | In distribution | |
| 9734723K | In distribution | |
| 9734297 | In distribution | |
| 9734715K | In distribution | |
| 9735264 | In distribution | |
| 9734960 | In distribution | |
| 9734402 | In distribution | |
| 9734649 | In distribution | |
| 9734301 | In distribution | |
| 9735306 | In distribution | |
| 9731184 | In distribution | |
| 9734656 | In distribution | |
| 9734914 | In distribution | |
| 9735314 | In distribution | |
| 9735109 | In distribution | |
| 9730819 | In distribution | |
| 9736271 | In distribution | |
| 9734259 | In distribution | |
| 9734274 | In distribution | |
| 9735253K | In distribution | |
| 9736270 | In distribution | |
| 9735220 | In distribution | |
| 9734906 | In distribution | |
| 9735204 | In distribution | |
| 9734742K | In distribution | |
| 9734906 | In distribution | |
| 9734590 | In distribution | |
| 9734661 | In distribution | |
| 9735281 | In distribution | |
| 9735252K | In distribution | |
| 9734741K | In distribution | |
| 9736477 | In distribution | |
| 9734838 | Outer Diameter 8.5 mm | In distribution |
| 9734644 | In distribution | |
| 961-578 | In distribution | |
| 9734493 | In distribution | |
| 9734335 | In distribution | |
| 961-576 | In distribution | |
| 9734724K | In distribution | |
| 9734678 | In distribution | |
| 9735047 | In distribution | |
| 961-574 | In distribution | |
| 9734752K | In distribution | |
| 9734559 | 10X26mm | In distribution |
| 9734492 | In distribution | |
| 9734682 | In distribution | |
| 9734631 | In distribution | |
| 9734374 | In distribution | |
| 9734494 | In distribution | |
| 9734947 | In distribution | |
| 9734238 | In distribution | |
| 9735501 | In distribution | |
| 9735488 | In distribution | |
| 9734275 | In distribution | |
| 9734947 | In distribution | |
| 9735204 | In distribution | |
| 9734491 | In distribution | |
| 9735280 | In distribution | |
| 9734646 | In distribution | |
| 9735249 | In distribution | |
| 9734678 | In distribution | |
| 9734723 | In distribution | |
| 9734299 | Outer Diameter 5.0 mm | In distribution |
| 9734228 | In distribution | |
| 9736060 | In distribution | |
| 9734644 | In distribution | |
| 9734404 | In distribution | |
| 9734709 | In distribution | |
| 9733235 | Length 100.0 mm | In distribution |
| 9735279 | In distribution | |
| 9734708 | In distribution | |
| 9734914 | In distribution | |
| 9734752K | In distribution | |
| 9734403 | In distribution | |
| 9735252K | In distribution | |
| 9734296 | In distribution | |
| 9735143 | In distribution | |
| 9734644 | In distribution | |
| 9730821 | In distribution | |
| 9735106 | In distribution | |
| 9734300 | In distribution | |
| 9735305 | 5.5-6.5mm | In distribution |
| 9734563 | 12X26mm | In distribution |
| 9735032 | In distribution | |
| 9734911 | In distribution | |
| 9734707 | In distribution | |
| 9735502 | In distribution | |
| 9735500 | In distribution | |
| 9734240 | In distribution | |
| 9735207 | In distribution | |
| 9735274 | In distribution | |
| 9734660 | In distribution | |
| 9735101 | In distribution | |
| 9735103 | In distribution | |
| 9734715K | In distribution | |
| 9731183 | In distribution | |
| 9734301 | Outer Diameter 6.0 mm | In distribution |
| 9734743K | In distribution | |
| 9735025 | In distribution | |
| 9735032 | In distribution | |
| 961-581 | In distribution | |
| 9736272 | In distribution | |
| 961-578 | In distribution | |
| 9735251K | In distribution | |
| 9734555 | 8X26mm | In distribution |
| 9735106 | In distribution | |
| 9736269 | In distribution | |
| 9736268 | In distribution | |
| 9735304 | 4.5-5.5mm | In distribution |
| 9735740 | In distribution | |
| 9735251K | In distribution | |
| 9734590 | In distribution | |
| 9735051 | In distribution | |
| 961-579 | In distribution | |
| 9734436 | In distribution | |
| 9734490 | In distribution | |
| 9734715K | In distribution | |
| 9735107 | In distribution | |
| 9735303 | 4.0-4.5mm | In distribution |
| 9734911 | In distribution | |
| 9734835 | In distribution | |
| 9735151 | Outer Diameter 4.5 mm | In distribution |
| 9735205 | In distribution | |
| 9735285 | In distribution | |
| 961-574 | In distribution | |
| 9734907 | In distribution | |
| 9734950 | In distribution | |
| 9734715K | In distribution | |
| 9734710 | In distribution | |
| 9734645 | In distribution | |
| 9734303 | Outer Diameter 7.5 mm | In distribution |
| 9735103 | In distribution | |
| 9734833 | In distribution | |
| 9734960 | In distribution | |
| 9735287 | In distribution | |
| 961-574 | In distribution | |
| 9735102 | In distribution | |
| 9734913 | In distribution | |
| 9734489 | In distribution | |
| 9735306 | 6.5-7.5mm | In distribution |
| 9734838 | In distribution | |
| 9734951 | In distribution | |
| 9733236 | Length 150.0 mm | In distribution |
| 961-573 | In distribution | |
| 9735253K | In distribution | |
| 9735283 | In distribution | |
| 9735271 | In distribution | |
| 9734956 | In distribution | |
| 9734716K | In distribution | |
| 9735108 | In distribution | |
| 9734278 | In distribution | |
| 9735109 | In distribution | |
| 9734908 | In distribution | |
| 9735500 | In distribution | |
| 9734435 | In distribution | |
| 9734404 | In distribution | |
| 961-579 | In distribution | |
| 9735283 | 5.5/6 mm | In distribution |
| 9734433 | In distribution | |
| 9734738K | In distribution | |
| 9734752 | In distribution | |
| 9734954 | In distribution | |
| 9735282 | In distribution | |
| 9735263 | In distribution | |
| 9735251K | In distribution | |
| 9734715 | In distribution | |
| 9733816 | In distribution | |
| 9734953 | In distribution | |
| 9734833 | In distribution | |
| 9734489 | In distribution | |
| 9734951 | In distribution | |
| 9735501 | In distribution | |
| 9735607 | In distribution | |
| 9735500 | In distribution | |
| 9734296 | Outer Diameter 3.75 mm | In distribution |
| 9734752K | In distribution | |
| 9735522 | In distribution | |
| 9735252K | In distribution | |
| 9734437 | In distribution | |
| 9736746 | In distribution | |
| 9734738 | In distribution | |
| 9735277 | In distribution | |
| 9734723K | In distribution | |
| 9734303 | In distribution | |
| 9735105 | In distribution | |
| 9735502 | In distribution | |
| 9734493 | In distribution | |
| 9734228 | In distribution | |
| 9734906 | In distribution | |
| 9734907 | In distribution | |
| 9735024 | In distribution | |
| 9734743K | 6.35 | In distribution |
| 9734705 | In distribution | |
| 9735284 | In distribution | |
| 9734655 | In distribution | |
| 9734299 | In distribution | |
| 9734302 | Outer Diameter 6.5 mm | In distribution |
| 9734648 | In distribution | |
| 9734914 | In distribution | |
| 9735253 | In distribution | |
| 9734956 | In distribution | |
| 9735142 | In distribution | |
| 961-581 | In distribution | |
| 9734723K | In distribution | |
| 9734957 | In distribution | |
| 9735449K | In distribution | |
| 9734716 | In distribution | |
| 9734435 | In distribution | |
| 9734716K | In distribution | |
| 9735277 | In distribution | |
| 9734403 | In distribution | |
| 9734437 | In distribution | |
| 9734283 | 4.5-5.5 | In distribution |
| 9735107 | In distribution | |
| 9734683 | In distribution | |
| 9735287 | In distribution | |
| 9734590 | In distribution | |
| 9735105 | In distribution | |
| 9735206 | In distribution | |
| 9735313 | In distribution | |
| 9735522 | In distribution | |
| 9734402 | In distribution | |
| 9734683 | In distribution | |
| 9735255K | In distribution | |
| 9734275 | In distribution | |
| 9735304 | In distribution | |
| 9736745 | In distribution | |
| 9734304 | Outer Diameter 8.5 mm | In distribution |
| 9734953 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Orthopedic Stereotaxic Instrument | Mako Surgical Corp. | 124 |
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
4 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Navigation, Inc. | UDI-DI | 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 | |
| Medtronic Navigation, Inc. | UDI-DI | 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 | |
| Medtronic Navigation, Inc. | UDI-DI | 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 | |
| Medtronic Navigation, Inc. | 510(k) number | 2019-08-28 | Class II | Employee error | Product was incorrectly assembled which could affect navigation accuracy of the device. | 1 unit | 2021-05-05 |
Recalls
10 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 |
|---|---|---|---|---|---|
| 2024-08-22 | 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 | |
| 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 | |
| 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.