Vital™ Navigation System
21 catalogue numbers from 854M4055, listed by Biomet Spine, United States, under Orthopedic Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
21catalogue numbers in this listing
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 | Biomet Spine, United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Record published | 2022-03-24 |
| Record revised | 2025-01-03 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 854M4055 | PASIT STYLUS 55MM | In distribution |
| 854M4010 | PAT TAP STYLUS NON-RATCHETING | In distribution |
| 854M4000 | PAT TAP STYLUS | In distribution |
| 854M4050 | PASIT STYLUS 50MM | In distribution |
| 854M4075 | PASIT STYLUS 75MM | In distribution |
| 854M4105 | PASIT STYLUS 105MM | In distribution |
| 854M4060 | PASIT STYLUS 60MM | In distribution |
| 854M4030 | PASIT STYLUS 30MM | In distribution |
| 854M4080 | PASIT STYLUS 80MM | In distribution |
| 854M4095 | PASIT STYLUS 95MM | In distribution |
| 854M4085 | PASIT STYLUS 85MM | In distribution |
| 854M4110 | PASIT STYLUS 110MM | In distribution |
| 854M4115 | PASIT STYLUS 115MM | In distribution |
| 854M4035 | PASIT STYLUS 35MM | In distribution |
| 854M4090 | PASIT STYLUS 90MM | In distribution |
| 854M4045 | PASIT STYLUS 45MM | In distribution |
| 854M4120 | PASIT STYLUS 120MM | In distribution |
| 854M4040 | PASIT STYLUS 40MM | In distribution |
| 854M4065 | PASIT STYLUS 65MM | In distribution |
| 854M4100 | PASIT STYLUS 100MM | In distribution |
| 854M4070 | PASIT STYLUS 70MM | 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
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.