Orthopedic Stereotaxic Instrument
ATP/Lateral Discectomy Instruments Lateral Cobb Elevator Angled Tip, Navigable Angled-Tip 12.7mm
5manufacturers in China registered for this device type
50catalogue 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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| 510(k) | K201661 |
| Record published | 2021-04-15 |
| Record revised | 2025-04-14 (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 |
| Distribution end date | 2024-06-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 302015120 | In distribution | |
| 289215116 | In distribution | |
| 286005326N | In distribution | |
| 3010-19-027 | In distribution | |
| 286005346N | In distribution | |
| 3010-19-035 | In distribution | |
| 3010-19-031 | In distribution | |
| 3010-19-026 | In distribution | |
| 3010-19-037 | In distribution | |
| 3010-19-032 | In distribution | |
| 3010-19-023 | In distribution | |
| 3010-19-022 | In distribution | |
| 302022012 | In distribution | |
| 302015100 | In distribution | |
| 302015025 | In distribution | |
| 286755010N | In distribution | |
| 302011017 | In distribution | |
| 289215012 | In distribution | |
| 3010-19-015 | In distribution | |
| 302015020 | In distribution | |
| 3010-19-040 | In distribution | |
| 289215011 | In distribution | |
| 3010-19-017 | In distribution | |
| 286005324N | In distribution | |
| 3010-19-021 | In distribution | |
| 286755001N | In distribution | |
| 3010-19-024 | In distribution | |
| 302011012 | In distribution | |
| 286005334N | In distribution | |
| 289215114 | In distribution | |
| 302015030 | In distribution | |
| 289215115 | In distribution | |
| 3010-19-033 | In distribution | |
| 3010-19-029 | In distribution | |
| 286755011N | In distribution | |
| 3010-19-030 | In distribution | |
| 3010-19-028 | In distribution | |
| 3010-19-020 | In distribution | |
| 3010-19-025 | In distribution | |
| 3010-19-014 | In distribution | |
| 289215113 | In distribution | |
| 3010-19-034 | In distribution | |
| 302011022 | In distribution | |
| 3010-19-018 | In distribution | |
| 286755005N | In distribution | |
| 3010-19-019 | In distribution | |
| 3010-19-016 | In distribution | |
| 289215112 | Withdrawn | |
| 289215010 | Withdrawn | |
| 289215111 | Withdrawn |
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 |
|---|---|
| K231527 | 2023-09-29 |
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.