Lonestar
Lonestar - Serrated Radial Ribs - Implant Caddy KIT (83-9106)
5manufacturers in China registered for this device type
170catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K161280 |
| Record published | 2019-03-19 |
| Record revised | 2026-02-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 84-5514 | In distribution | |
| 84-7514 | In distribution | |
| 83-7120 | In distribution | |
| 83-5506 | In distribution | |
| 83-5409 | In distribution | |
| 83-5507 | In distribution | |
| 83-7506 | In distribution | |
| 84-5610 | In distribution | |
| 83-7608 | In distribution | |
| 84-7413 | In distribution | |
| 83-7509 | In distribution | |
| 83-5412 | In distribution | |
| 83-3514 | In distribution | |
| 84-7313 | In distribution | |
| 84-7608 | In distribution | |
| 83-7411 | In distribution | |
| 83-3910 | In distribution | |
| 84-7611 | In distribution | |
| 83-3512 | In distribution | |
| 450420-0001 | In distribution | |
| 83-7314 | In distribution | |
| 84-5611 | In distribution | |
| 84-5306 | In distribution | |
| 84-7412 | In distribution | |
| 83-5611 | In distribution | |
| 83-3914 | In distribution | |
| 84-5406 | In distribution | |
| 83-5610 | In distribution | |
| 83-7609 | In distribution | |
| 84-7508 | In distribution | |
| 84-7512 | In distribution | |
| 84-5409 | In distribution | |
| 83-7307 | In distribution | |
| 83-5410 | In distribution | |
| 83-5607 | In distribution | |
| 84-7614 | In distribution | |
| 83-5511 | In distribution | |
| 83-7613 | In distribution | |
| 84-5608 | In distribution | |
| 84-5311 | In distribution | |
| 83-3418 | In distribution | |
| 83-5408 | In distribution | |
| 84-7510 | In distribution | |
| 84-7306 | In distribution | |
| 84-7307 | In distribution | |
| 83-7610 | In distribution | |
| 450678-0001 | In distribution | |
| 84-5508 | In distribution | |
| 84-7312 | In distribution | |
| 83-7309 | In distribution | |
| 83-7607 | In distribution | |
| 84-5512 | In distribution | |
| 83-7511 | In distribution | |
| 83-7512 | In distribution | |
| 83-5614 | In distribution | |
| 84-7308 | In distribution | |
| 83-3812 | In distribution | |
| 83-5406 | In distribution | |
| 83-3814 | In distribution | |
| 83-5309 | In distribution | |
| 83-7508 | In distribution | |
| 83-7407 | In distribution | |
| 83-5411 | In distribution | |
| 84-5314 | In distribution | |
| 84-5413 | In distribution | |
| 84-5613 | In distribution | |
| 83-7110 | In distribution | |
| 83-3510 | In distribution | |
| 84-7506 | In distribution | |
| 83-5308 | In distribution | |
| 84-5511 | In distribution | |
| 84-7513 | In distribution | |
| 83-7310 | In distribution | |
| 83-7514 | In distribution | |
| 450420-0002 | In distribution | |
| 83-7614 | In distribution | |
| 83-3416 | In distribution | |
| 83-5513 | In distribution | |
| 83-5313 | In distribution | |
| 83-5612 | In distribution | |
| 83-7606 | In distribution | |
| 84-7609 | In distribution | |
| 83-5407 | In distribution | |
| 83-7311 | In distribution | |
| 83-5312 | In distribution | |
| 84-5606 | In distribution | |
| 83-5314 | In distribution | |
| 83-3410 | In distribution | |
| 83-5413 | In distribution | |
| 84-7414 | In distribution | |
| 84-5614 | In distribution | |
| 83-7409 | In distribution | |
| 83-7408 | In distribution | |
| 83-3412 | In distribution | |
| 83-3810 | In distribution | |
| 84-7607 | In distribution | |
| 83-5609 | In distribution | |
| 83-7507 | In distribution | |
| 83-3816 | In distribution | |
| 84-5307 | In distribution | |
| 84-5509 | In distribution | |
| 83-7412 | In distribution | |
| 83-5514 | In distribution | |
| 84-7511 | In distribution | |
| 84-7610 | In distribution | |
| 84-7613 | In distribution | |
| 84-5510 | In distribution | |
| 83-7306 | In distribution | |
| 84-7406 | In distribution | |
| 84-7309 | In distribution | |
| 83-5509 | In distribution | |
| 84-5308 | In distribution | |
| 84-5408 | In distribution | |
| 83-7308 | In distribution | |
| 84-5506 | In distribution | |
| 83-7413 | In distribution | |
| 83-5512 | In distribution | |
| 84-5309 | In distribution | |
| 83-3918 | In distribution | |
| 84-5414 | In distribution | |
| 84-5313 | In distribution | |
| 83-3518 | In distribution | |
| 84-5609 | In distribution | |
| 83-7513 | In distribution | |
| 83-5510 | In distribution | |
| 83-5613 | In distribution | |
| 83-5310 | In distribution | |
| 84-5312 | In distribution | |
| 83-7510 | In distribution | |
| 84-7407 | In distribution | |
| 83-7406 | In distribution | |
| 83-3516 | In distribution | |
| 83-7611 | In distribution | |
| 84-7409 | In distribution | |
| 84-7408 | In distribution | |
| 83-7312 | In distribution | |
| 84-7311 | In distribution | |
| 84-5407 | In distribution | |
| 83-5306 | In distribution | |
| 83-7612 | In distribution | |
| 83-5508 | In distribution | |
| 83-3916 | In distribution | |
| 84-7411 | In distribution | |
| 84-7314 | In distribution | |
| 83-3414 | In distribution | |
| 83-5606 | In distribution | |
| 84-5607 | In distribution | |
| 84-7410 | In distribution | |
| 84-7606 | In distribution | |
| 83-7313 | In distribution | |
| 450423-0001 | In distribution | |
| 83-7410 | In distribution | |
| 84-5507 | In distribution | |
| 84-7310 | In distribution | |
| 84-7507 | In distribution | |
| 84-5410 | In distribution | |
| 83-5311 | In distribution | |
| 83-3818 | In distribution | |
| 83-5414 | In distribution | |
| 83-5307 | In distribution | |
| 83-3912 | In distribution | |
| 84-7612 | In distribution | |
| 84-5310 | In distribution | |
| 83-7414 | In distribution | |
| 84-5412 | In distribution | |
| 84-5513 | In distribution | |
| 84-7509 | In distribution | |
| 83-5608 | In distribution | |
| 84-5411 | In distribution | |
| 84-5612 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
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.