CD Horizon® Spinal System
Handle RBT030003 RG 5.5/6.0 Scalpel Long
5manufacturers in China registered for this device type
137catalogue 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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| 510(k) | K182121 |
| Record published | 2019-01-26 |
| Record revised | 2023-04-04 (version 7) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Outer diameter 3 mm |
| Distribution end date | 2023-11-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RBT030003 | In distribution | |
| RBT085334 | In distribution | |
| RBT034502 | In distribution | |
| RBT090004 | In distribution | |
| 25530019570 | In distribution | |
| RBT011009 | In distribution | |
| NAV5599005 | In distribution | |
| RBT052102 | In distribution | |
| RBT011005 | In distribution | |
| RBT090008 | In distribution | |
| RBT033301 | In distribution | |
| RBT011211 | In distribution | |
| RBT020003 | In distribution | |
| NAV5599015 | In distribution | |
| RBT043302 | In distribution | |
| 25530011260 | In distribution | |
| RBT054202 | In distribution | |
| RBT033302 | In distribution | |
| RBT033102 | In distribution | |
| RBT010000 | In distribution | |
| RBT090000 | In distribution | |
| RBT012203 | In distribution | |
| RBT085431 | In distribution | |
| NAV1400 | In distribution | |
| NAV2026 | In distribution | |
| NAV5599001 | In distribution | |
| 25740011170 | In distribution | |
| RBT051206 | In distribution | |
| RBT043202 | In distribution | |
| 25630019580 | In distribution | |
| RBT074210 | In distribution | |
| RBT023101 | In distribution | |
| RBT012202 | In distribution | |
| RBT062402 | In distribution | |
| RBT012204 | In distribution | |
| RBT090016 | In distribution | |
| 25740017580 | In distribution | |
| RBT090012 | In distribution | |
| RBT062401 | Outer Diameter 3.0 mm | In distribution |
| RBT043301 | In distribution | |
| 25630018560 | In distribution | |
| RBT024502 | In distribution | |
| RBT023202 | In distribution | |
| RBT012101 | Outer Diameter 3.0 mm | In distribution |
| 25840011170 | In distribution | |
| 25840018580 | In distribution | |
| NAV2022 | In distribution | |
| RBT052202 | In distribution | |
| 25840011260 | In distribution | |
| RBT012201 | In distribution | |
| RBT023201 | In distribution | |
| 25530011280 | In distribution | |
| RBT034201 | In distribution | |
| RBT085432 | In distribution | |
| RBT071660 | In distribution | |
| RBT024102 | In distribution | |
| RBT090015 | In distribution | |
| 25740011080 | In distribution | |
| 25630011190 | In distribution | |
| NAV5599020 | In distribution | |
| RBT024101 | In distribution | |
| RBT011204 | In distribution | |
| RBT011008 | In distribution | |
| RBT011206 | In distribution | |
| RBT011007 | In distribution | |
| NAV5599010 | In distribution | |
| RBT085332 | In distribution | |
| RBT085331 | In distribution | |
| RBT051208 | In distribution | |
| NAV1095 | In distribution | |
| RBT051210 | In distribution | |
| RBT071665 | In distribution | |
| RBT075710 | In distribution | |
| RBT043201 | In distribution | |
| 25840017570 | In distribution | |
| NAV0095 | In distribution | |
| 25740011270 | In distribution | |
| RBT085434 | In distribution | |
| RBT053102 | In distribution | |
| RBT034202 | In distribution | |
| RBT051211 | In distribution | |
| RBT085810 | In distribution | |
| RBT023302 | In distribution | |
| RBT011011 | In distribution | |
| RBT050000 | In distribution | |
| RBT023301 | In distribution | |
| NAV2024 | In distribution | |
| 25740019590 | In distribution | |
| 25740017511 | In distribution | |
| RBT085330 | In distribution | |
| 25740017590 | In distribution | |
| 25530017550 | In distribution | |
| RBT062403 | In distribution | |
| RBT090009 | In distribution | |
| RBT011003 | In distribution | |
| NAV5599000 | In distribution | |
| 25000065 | In distribution | |
| 25530011011 | In distribution | |
| RBT011210 | In distribution | |
| RBT071655 | In distribution | |
| NAV5599006 | In distribution | |
| RBT024501 | In distribution | |
| RBT085710 | In distribution | |
| 25530019512 | In distribution | |
| RBT090007 | In distribution | |
| 25630011060 | In distribution | |
| RBT012102 | In distribution | |
| RBT085430 | In distribution | |
| 25530019510 | In distribution | |
| RBT011004 | In distribution | |
| 25630017570 | In distribution | |
| RBT033101 | In distribution | |
| RBT034501 | In distribution | |
| RBT011012 | In distribution | |
| RBT076210 | In distribution | |
| RBT011205 | In distribution | |
| 25740018510 | In distribution | |
| RBT011207 | In distribution | |
| RBT023102 | In distribution | |
| RBT074110 | In distribution | |
| RBT075810 | In distribution | |
| RBT051207 | In distribution | |
| RBT090003 | In distribution | |
| RBT011010 | In distribution | |
| RBT011209 | In distribution | |
| RBT011212 | In distribution | |
| RBT071560 | In distribution | |
| RBT051209 | In distribution | |
| RBT011208 | In distribution | |
| 25740017510 | In distribution | |
| RBT011203 | In distribution | |
| 25630011011 | In distribution | |
| RBT011006 | In distribution | |
| 25840018512 | Withdrawn | |
| 25530019513 | Withdrawn | |
| 25840011212 | Withdrawn | |
| 25630011114 | 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 |
| 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 |
|---|---|
| K230716 | 2023-07-18 |
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 Sofamor Danek USA, Inc. | 510(k) number | 2023-07-12 | Class II | Under Investigation by firm | Incorrect Laser Marking – Solera Awl Tip Tap | 13 devices |
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.