Zero-P
Zero-P Implant 10MM Height Lordotic/Large-Sterile
5manufacturers in China registered for this device type
99catalogue 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 | Synthes Gmbh, Switzerland |
|---|---|
| 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, Manufacturer, Exporter |
| 510(k) | K112459 |
| Record published | 2015-09-14 |
| Record revised | 2022-07-14 (version 6) |
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 |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03.617.755 | In distribution | |
| 03.617.766 | In distribution | |
| 04.617.119S | In distribution | |
| 03.617.756 | In distribution | |
| 03.617.799 | In distribution | |
| 04.617.226S | In distribution | |
| 03.617.720 | In distribution | |
| 03.617.727 | In distribution | |
| 04.617.116S | In distribution | |
| 04.617.235S | In distribution | |
| 04.617.220S | In distribution | |
| 03.617.732 | In distribution | |
| 03.617.722 | In distribution | |
| 04.617.237S | In distribution | |
| 04.617.111S | In distribution | |
| 03.617.787 | In distribution | |
| 03.617.739 | In distribution | |
| 03.617.762 | In distribution | |
| 03.617.737 | In distribution | |
| 03.617.767 | In distribution | |
| 04.617.121S | In distribution | |
| 03.617.786 | In distribution | |
| 03.617.758 | In distribution | |
| 04.617.217S | In distribution | |
| 04.617.115S | In distribution | |
| 04.617.110S | In distribution | |
| 04.617.219S | In distribution | |
| 03.617.789 | In distribution | |
| 04.617.117S | In distribution | |
| SD03.617.901 | In distribution | |
| 04.617.222S | In distribution | |
| 03.617.790 | In distribution | |
| 03.617.768 | In distribution | |
| 03.617.759 | In distribution | |
| 04.617.236S | In distribution | |
| 04.617.136S | In distribution | |
| 03.617.757 | In distribution | |
| 04.617.228S | In distribution | |
| 03.617.730 | In distribution | |
| 03.617.781 | In distribution | |
| 04.617.221S | In distribution | |
| 04.617.229S | In distribution | |
| SD03.617.962 | In distribution | |
| 03.617.736 | In distribution | |
| 04.617.130S | In distribution | |
| 04.617.232S | In distribution | |
| 03.617.769 | In distribution | |
| 03.617.729 | In distribution | |
| 04.617.138S | In distribution | |
| 04.617.139S | In distribution | |
| 03.617.782 | In distribution | |
| 03.617.738 | In distribution | |
| 04.617.210S | In distribution | |
| 03.617.728 | In distribution | |
| 03.617.798 | In distribution | |
| 04.617.212S | In distribution | |
| 04.617.132S | In distribution | |
| 04.617.126S | In distribution | |
| 04.617.125S | In distribution | |
| 03.617.721 | In distribution | |
| 03.617.725 | In distribution | |
| 03.617.797 | In distribution | |
| 04.617.225S | In distribution | |
| 04.617.122S | In distribution | |
| 04.617.230S | In distribution | |
| 03.617.760 | In distribution | |
| 04.617.215S | In distribution | |
| 04.617.218S | In distribution | |
| 03.617.765 | In distribution | |
| 03.617.795 | In distribution | |
| 04.617.239S | In distribution | |
| 03.617.785 | In distribution | |
| 04.617.227S | In distribution | |
| 04.617.216S | In distribution | |
| 03.617.751 | In distribution | |
| 04.617.231S | In distribution | |
| 03.617.761 | In distribution | |
| 03.617.788 | In distribution | |
| 04.617.128S | In distribution | |
| 03.617.750 | In distribution | |
| 04.617.127S | In distribution | |
| 04.617.211S | In distribution | |
| 03.617.726 | In distribution | |
| 04.617.129S | In distribution | |
| 03.617.752 | In distribution | |
| 04.617.112S | In distribution | |
| 04.617.131S | In distribution | |
| 03.617.792 | In distribution | |
| 03.617.735 | In distribution | |
| 03.617.731 | In distribution | |
| 04.617.118S | In distribution | |
| 04.617.137S | In distribution | |
| 03.617.791 | In distribution | |
| 04.617.120S | In distribution | |
| 03.617.796 | In distribution | |
| SD03.617.900 | In distribution | |
| 04.617.135S | In distribution | |
| 04.617.238S | In distribution | |
| 03.617.780 | 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.