Monet Anterior Cervical Interbody Fusion Cage System With Supplementary Fixation
MONET™ Supplementary Fixation Plate, Medium, 2 Holes, H12mm
5manufacturers in China registered for this device type
172catalogue numbers in this listing
1510(k) clearance
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 | CTL Medical Corporation, 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 |
| 510(k) | K182151 |
| Record published | 2019-10-25 |
| Record revised | 2026-05-07 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 113.1109 | In distribution | |
| 113.1308 | In distribution | |
| 113.0126 | In distribution | |
| 113.1606 | In distribution | |
| 113.1307 | In distribution | |
| 113.0516 | In distribution | |
| 113.0811 | In distribution | |
| 113.0318 | In distribution | |
| 113.8010 | In distribution | |
| 113.0814 | In distribution | |
| 113.0418 | In distribution | |
| 113.0619 | In distribution | |
| 113.0228 | In distribution | |
| 113.7407 | In distribution | |
| 113.1608 | In distribution | |
| 113.0118 | In distribution | |
| 113.0411 | In distribution | |
| 113.1409 | In distribution | |
| 113.0716 | In distribution | |
| 113.0120 | In distribution | |
| 113.8110 | In distribution | |
| 113.8150 | In distribution | |
| 113.0519 | In distribution | |
| 113.0613 | In distribution | |
| 113.0712 | In distribution | |
| 113.0210 | In distribution | |
| 113.0415 | In distribution | |
| 113.1108 | In distribution | |
| 113.0713 | In distribution | |
| 113.1612 | In distribution | |
| 113.7429 | In distribution | |
| 113.7604 | In distribution | |
| 113.1306 | In distribution | |
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| L.113.1209 | In distribution | |
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| 113.0316 | In distribution | |
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| 113.1508 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182151 | 2018-10-11 |
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.