AVS Anchor-C
Inserter-Guide LOW Profile
5manufacturers in China registered for this device type
73catalogue 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 | Stryker 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 | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-14 |
| Record revised | 2024-09-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Height 6 to 12 mm; depth 12 to 14 mm; angle 0 to 8 °; width 14 to 16 mm; length 8 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48321088 | Depth 12.0 mm | In distribution |
| 48328009 | Height 9.0 mm | In distribution |
| 48321108 | Angle 8.0 ° | In distribution |
| 48321090 | Height 9.0 mm | In distribution |
| 48321114 | Depth 12.0 mm | In distribution |
| 48321128 | Depth 12.0 mm | In distribution |
| 48323064 | Angle 4.0 ° | In distribution |
| 48323090 | Depth 14.0 mm | In distribution |
| 48323078 | Angle 8.0 ° | In distribution |
| 48323080 | Width 16.0 mm | In distribution |
| 48321094 | Width 14.0 mm | In distribution |
| 48323100 | Angle 0.0 ° | In distribution |
| 48321110 | Depth 12.0 mm | In distribution |
| 48327009 | Height 9.0 mm | In distribution |
| 48328006 | Height 6.0 mm | In distribution |
| 48328008 | Height 8.0 mm | In distribution |
| 48323088 | Depth 14.0 mm | In distribution |
| 48323108 | Depth 14.0 mm | In distribution |
| 48325312 | Diameter: 3.5 Millimeter | In distribution |
| 48321084 | Angle 4.0 ° | In distribution |
| 48328007 | Height 7.0 mm | In distribution |
| 48321104 | Depth 12.0 mm | In distribution |
| 48325414 | Diameter: 4.0 Millimeter | In distribution |
| 48321120 | Angle 0.0 ° | In distribution |
| 48335310 | Diameter: 3.5 Millimeter | In distribution |
| 48321070 | Height 7.0 mm | In distribution |
| 48335312 | Diameter: 3.5 Millimeter | In distribution |
| 48327012 | Height 12.0 mm | In distribution |
| 48325310 | Length 10.0 mm | In distribution |
| 48321060 | Width 14.0 mm | In distribution |
| 48335414 | Length 14.0 mm | In distribution |
| 48327011 | Height 11.0 mm | In distribution |
| 48323060 | Width 16.0 mm | In distribution |
| 48327008 | Height 8.0 mm | In distribution |
| 48323068 | Angle 8.0 ° | In distribution |
| 48321080 | Height 8.0 mm | In distribution |
| 48323110 | Width 16.0 mm | In distribution |
| 48323104 | Height 10.0 mm | In distribution |
| 48321118 | Angle 8.0 ° | In distribution |
| 48321098 | Angle 8.0 ° | In distribution |
| 48323124 | Height 12.0 mm | In distribution |
| 48323074 | Width 16.0 mm | In distribution |
| 48328012 | Height 12.0 mm | In distribution |
| 48321100 | Angle 0.0 ° | In distribution |
| 48323094 | Depth 14.0 mm | In distribution |
| 48323118 | Width 16.0 mm | In distribution |
| 48327010 | Height 10.0 mm | In distribution |
| 48325408 | Length 8.0 mm | In distribution |
| 48321078 | Angle 8.0 ° | In distribution |
| 48335314 | Diameter: 3.5 Millimeter | In distribution |
| 48327000 | In distribution | |
| 48327006 | Height 6.0 mm | In distribution |
| 48327007 | Height 7.0 mm | In distribution |
| 48323098 | Width 16.0 mm | In distribution |
| 48335410 | Length 10.0 mm | In distribution |
| 48335412 | Length 12.0 mm | In distribution |
| 48323128 | Width 16.0 mm | In distribution |
| 48325410 | Diameter: 4.0 Millimeter | In distribution |
| 48323084 | Angle 4.0 ° | In distribution |
| 48323120 | Width 16.0 mm | In distribution |
| 48328010 | Height 10.0 mm | In distribution |
| 48321074 | Height 7.0 mm | In distribution |
| 48321064 | Angle 4.0 ° | In distribution |
| 48323070 | Depth 14.0 mm | In distribution |
| 48321124 | Height 12.0 mm | In distribution |
| 48325314 | Diameter: 3.5 Millimeter | In distribution |
| 48335308 | Diameter: 3.5 Millimeter | In distribution |
| 48323114 | Width 16.0 mm | In distribution |
| 48321068 | Width 14.0 mm | In distribution |
| 48325412 | Diameter: 4.0 Millimeter | In distribution |
| 48325308 | Length 8.0 mm | In distribution |
| 48328011 | Height 11.0 mm | In distribution |
| 48335408 | Length 8.0 mm | 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.