Zavation F3D-Z CIF
F3D-Z CIF 13mmx15mmx12mm -10 deg
3manufacturers in China registered for this device type
120catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Zavation, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2025-06-25 |
| Record revised | 2025-11-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 913-0008 | In distribution | |
| 914-0607 | In distribution | |
| 913-0607 | In distribution | |
| 911-0007 | In distribution | |
| 911-0005 | In distribution | |
| 912-0008 | In distribution | |
| 914-0610 | In distribution | |
| 911-0606 | In distribution | |
| 914-1007 | In distribution | |
| 914-0612 | In distribution | |
| 911-1012 | In distribution | |
| 913-0010 | In distribution | |
| 914-1009 | In distribution | |
| 910-0011 | In distribution | |
| 911-0012 | In distribution | |
| 912-0608 | In distribution | |
| 910-0008 | In distribution | |
| 912-1012 | In distribution | |
| 911-0605 | In distribution | |
| 913-0606 | In distribution | |
| 912-0609 | In distribution | |
| 910-1007 | In distribution | |
| 910-0611 | In distribution | |
| 912-1005 | In distribution | |
| 912-0612 | In distribution | |
| 910-0612 | In distribution | |
| 913-0006 | In distribution | |
| 910-0605 | In distribution | |
| 912-1010 | In distribution | |
| 913-0009 | In distribution | |
| 912-0011 | In distribution | |
| 911-1009 | In distribution | |
| 911-0011 | In distribution | |
| 914-0010 | In distribution | |
| 913-1010 | In distribution | |
| 912-1008 | In distribution | |
| 913-0012 | In distribution | |
| 913-1012 | In distribution | |
| 914-1008 | In distribution | |
| 910-0005 | In distribution | |
| 914-0611 | In distribution | |
| 913-0005 | In distribution | |
| 912-0606 | In distribution | |
| 911-0609 | In distribution | |
| 911-0009 | In distribution | |
| 913-0611 | In distribution | |
| 911-0611 | In distribution | |
| 911-0610 | In distribution | |
| 911-0608 | In distribution | |
| 913-1009 | In distribution | |
| 912-0611 | In distribution | |
| 913-1007 | In distribution | |
| 914-0609 | In distribution | |
| 910-0007 | In distribution | |
| 914-0005 | In distribution | |
| 912-0607 | In distribution | |
| 913-1005 | In distribution | |
| 913-0612 | In distribution | |
| 912-0605 | In distribution | |
| 911-1011 | In distribution | |
| 910-0010 | In distribution | |
| 913-0609 | In distribution | |
| 911-0006 | In distribution | |
| 914-0012 | In distribution | |
| 910-1010 | In distribution | |
| 911-1005 | In distribution | |
| 914-0008 | In distribution | |
| 912-1007 | In distribution | |
| 910-1012 | In distribution | |
| 911-1007 | In distribution | |
| 911-0607 | In distribution | |
| 913-0608 | In distribution | |
| 910-0606 | In distribution | |
| 914-0006 | In distribution | |
| 912-0012 | In distribution | |
| 910-0609 | In distribution | |
| 910-1006 | In distribution | |
| 910-0607 | In distribution | |
| 914-0608 | In distribution | |
| 911-0612 | In distribution | |
| 912-1009 | In distribution | |
| 910-1008 | In distribution | |
| 910-1005 | In distribution | |
| 913-1008 | In distribution | |
| 912-1011 | In distribution | |
| 910-0012 | In distribution | |
| 911-1008 | In distribution | |
| 914-0009 | In distribution | |
| 910-0009 | In distribution | |
| 912-0007 | In distribution | |
| 912-0010 | In distribution | |
| 913-0610 | In distribution | |
| 914-0606 | In distribution | |
| 911-1006 | In distribution | |
| 912-0006 | In distribution | |
| 914-1010 | In distribution | |
| 914-0007 | In distribution | |
| 910-0608 | In distribution | |
| 913-0007 | In distribution | |
| 910-1011 | In distribution | |
| 914-1005 | In distribution | |
| 914-1006 | In distribution | |
| 910-0610 | In distribution | |
| 914-1012 | In distribution | |
| 914-0011 | In distribution | |
| 912-0005 | In distribution | |
| 911-0008 | In distribution | |
| 913-1006 | In distribution | |
| 913-1011 | In distribution | |
| 910-1009 | In distribution | |
| 912-0009 | In distribution | |
| 914-0605 | In distribution | |
| 911-1010 | In distribution | |
| 912-0610 | In distribution | |
| 910-0006 | In distribution | |
| 913-0605 | In distribution | |
| 912-1006 | In distribution | |
| 913-0011 | In distribution | |
| 911-0010 | In distribution | |
| 914-1011 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142271 | 2014-12-19 |
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.