Intervertebral Fusion Device With Integrated Fixation, Cervical
3.7MM TI Cervical Spine Screw SLF-Tpng/Variable Angle 14MM
5manufacturers in China registered for this device type
54catalogue 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) | K112068 |
| Record published | 2015-09-14 |
| Record revised | 2026-05-11 (version 8) |
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 | Per pack | Status |
|---|---|---|---|
| 03.647.962 | In distribution | ||
| SD03.617.995 | In distribution | ||
| 03.617.990 | In distribution | ||
| 03.647.985 | In distribution | ||
| 04.617.814 | In distribution | ||
| 04.647.874 | In distribution | ||
| SD03.617.914 | In distribution | ||
| SD03.617.916 | In distribution | ||
| SD03.617.912 | In distribution | ||
| 03.617.904 | In distribution | ||
| 03.647.982 | In distribution | ||
| 04.647.834S | In distribution | ||
| 04.647.832 | In distribution | ||
| 03.617.980 | In distribution | ||
| 03.647.980 | In distribution | ||
| 04.617.816 | In distribution | ||
| 04.647.834 | In distribution | ||
| 04.647.872 | In distribution | ||
| 03.647.993 | In distribution | ||
| 03.647.972 | In distribution | ||
| SD03.647.995 | In distribution | ||
| 04.617.816.02S | 2 | In distribution | |
| 03.647.971 | In distribution | ||
| 03.617.905 | In distribution | ||
| 04.647.836 | In distribution | ||
| 03.617.901 | In distribution | ||
| 04.647.874S | In distribution | ||
| SD03.617.993 | In distribution | ||
| SD03.647.993 | In distribution | ||
| 03.617.968 | In distribution | ||
| 03.617.907 | In distribution | ||
| 03.647.901 | In distribution | ||
| 03.647.964 | In distribution | ||
| 03.647.994 | In distribution | ||
| 03.617.963 | In distribution | ||
| 03.617.975S | In distribution | ||
| 03.617.962 | In distribution | ||
| 04.617.812 | In distribution | ||
| 03.617.982 | In distribution | ||
| 03.617.971S | In distribution | ||
| 04.647.872S | In distribution | ||
| 04.647.878S | In distribution | ||
| SD03.617.902 | In distribution | ||
| 03.617.993 | In distribution | ||
| 04.617.812.02S | 2 | In distribution | |
| 03.617.972 | In distribution | ||
| 04.647.876S | In distribution | ||
| 04.617.814.02S | 2 | In distribution | |
| 03.617.902 | In distribution | ||
| 04.647.876 | In distribution | ||
| 03.617.900 | In distribution | ||
| 04.647.836S | In distribution | ||
| 03.647.990 | In distribution | ||
| 04.647.878 | 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
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 | Closed |
|---|---|---|---|---|---|---|---|
| Synthes USA (HQ), Inc. | 510(k) number | 2013-09-30 | Class II | Process design | A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw. | 1 | 2015-04-16 |
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.