Erisma® Lp_navigated Instruments
Erisma-LP Navigated Instruments are manual tools used with Medtronic StealthStation to locate anatomy during preparation and placement of Erisma-LP or Erisma-MIS pedicle screws. The range…
Erisma-LP Navigated Instruments are manual tools used with Medtronic StealthStation to locate anatomy during preparation and placement of Erisma-LP or Erisma-MIS pedicle screws. The range includes drivers, a tap, bone awl and probes.
A listed straight thoracic probe is one instrument in the set. The instruments use medical-grade stainless steel and titanium alloy across their components.
Listed Item
Erisma-LP NAV Straight Thoracic Probe
Navigation and Reuse
The instruments are designed to register with StealthStation hardware and software in open, minimally invasive or percutaneous procedures. They are supplied nonsterile and reusable. Navigation supplies positional reference while the surgeon manipulates the manual instrument.
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 | Clariance, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K202956 |
| Record published | 2021-03-31 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48710005 | In distribution | |
| 48701045 | In distribution | |
| 48710004 | In distribution | |
| 99780004 | In distribution | |
| 48710003 | In distribution | |
| 48702001 | In distribution | |
| 48701175 | In distribution | |
| 48701145 | In distribution | |
| 48701165 | In distribution | |
| 48701055 | In distribution | |
| 48701065 | In distribution | |
| 48701075 | In distribution | |
| 48701085 | In distribution | |
| 48731000 | In distribution | |
| 48731001 | In distribution | |
| 48701155 | In distribution | |
| 48701185 | 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 |
|---|---|
| K202956 | 2021-02-26 |
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.