Synfix Evolution
Synfix® Evolution Mini-Open Driver W/O Thread Lock Sleeve
3manufacturers in China registered for this device type
143catalogue numbers in this listing
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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K150673 |
| Record published | 2019-07-29 |
| Record revised | 2024-09-11 (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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 03.835.401 | In distribution | ||
| 08.815.131S | In distribution | ||
| 08.815.223S | In distribution | ||
| 08.815.143S | In distribution | ||
| 03.835.001 | In distribution | ||
| 08.815.116S | In distribution | ||
| 08.815.332S | In distribution | ||
| 08.815.366S | In distribution | ||
| 08.815.135S | In distribution | ||
| 08.815.304S | In distribution | ||
| 08.815.303S | In distribution | ||
| 08.815.212S | In distribution | ||
| 08.815.112S | In distribution | ||
| 08.815.154S | In distribution | ||
| 08.815.345S | In distribution | ||
| 08.815.133S | In distribution | ||
| 08.815.123S | In distribution | ||
| 08.815.226S | In distribution | ||
| 08.815.301S | In distribution | ||
| 04.835.130.02S | 2 | In distribution | |
| 04.835.225.02S | 2 | In distribution | |
| 08.815.326S | In distribution | ||
| 08.815.132S | In distribution | ||
| 08.815.146S | In distribution | ||
| 08.815.352S | In distribution | ||
| 08.815.125S | In distribution | ||
| 08.815.353S | In distribution | ||
| 08.815.335S | In distribution | ||
| 08.815.255S | In distribution | ||
| 08.815.375S | In distribution | ||
| 08.815.136S | In distribution | ||
| 03.835.403 | In distribution | ||
| 08.815.276S | In distribution | ||
| 08.815.141S | In distribution | ||
| 08.815.122S | In distribution | ||
| 08.815.275S | In distribution | ||
| 08.815.311S | In distribution | ||
| 03.835.416 | In distribution | ||
| 08.815.211S | In distribution | ||
| 08.815.315S | In distribution | ||
| 08.815.244S | In distribution | ||
| 08.815.166S | In distribution | ||
| 08.815.273S | In distribution | ||
| 08.815.355S | In distribution | ||
| 03.835.002 | In distribution | ||
| 08.815.202S | In distribution | ||
| 08.815.323S | In distribution | ||
| 08.815.274S | In distribution | ||
| 08.815.305S | In distribution | ||
| 08.815.302S | In distribution | ||
| 08.815.102S | In distribution | ||
| 08.815.363S | In distribution | ||
| 08.815.126S | In distribution | ||
| 08.815.234S | In distribution | ||
| 08.815.152S | In distribution | ||
| 08.815.241S | In distribution | ||
| 08.815.322S | In distribution | ||
| 04.835.125.02S | 2 | In distribution | |
| 08.815.233S | In distribution | ||
| 08.815.343S | In distribution | ||
| 08.815.256S | In distribution | ||
| 08.815.316S | In distribution | ||
| 08.815.254S | In distribution | ||
| 08.815.376S | In distribution | ||
| 08.815.176S | In distribution | ||
| 08.815.324S | In distribution | ||
| 08.815.144S | In distribution | ||
| 08.815.134S | In distribution | ||
| 08.815.231S | In distribution | ||
| 03.835.402 | In distribution | ||
| 08.815.153S | In distribution | ||
| 08.815.365S | In distribution | ||
| 03.835.413 | In distribution | ||
| 04.835.220.02S | 2 | In distribution | |
| 08.815.105S | In distribution | ||
| 04.835.230.02S | 2 | In distribution | |
| 03.835.410 | In distribution | ||
| 08.815.306S | In distribution | ||
| 03.835.006 | In distribution | ||
| 08.815.213S | In distribution | ||
| 08.815.204S | In distribution | ||
| 08.815.331S | In distribution | ||
| 08.815.253S | In distribution | ||
| 08.815.313S | In distribution | ||
| 04.835.120.02S | 2 | In distribution | |
| 08.815.215S | In distribution | ||
| 08.815.263S | In distribution | ||
| 08.815.205S | In distribution | ||
| 08.815.264S | In distribution | ||
| 03.835.003 | In distribution | ||
| 08.815.341S | In distribution | ||
| 08.815.344S | In distribution | ||
| 08.815.203S | In distribution | ||
| 08.815.174S | In distribution | ||
| 08.815.333S | In distribution | ||
| 08.815.346S | In distribution | ||
| 08.815.235S | In distribution | ||
| 08.815.245S | In distribution | ||
| 08.815.163S | In distribution | ||
| 08.815.206S | In distribution | ||
| 08.815.236S | In distribution | ||
| 08.815.266S | In distribution | ||
| 08.815.175S | In distribution | ||
| 08.815.114S | In distribution | ||
| 08.815.164S | In distribution | ||
| 08.815.113S | In distribution | ||
| 08.815.265S | In distribution | ||
| 08.815.354S | In distribution | ||
| 08.815.373S | In distribution | ||
| 08.815.165S | In distribution | ||
| 08.815.111S | In distribution | ||
| 08.815.242S | In distribution | ||
| 08.815.356S | In distribution | ||
| 08.815.224S | In distribution | ||
| 08.815.222S | In distribution | ||
| 08.815.246S | In distribution | ||
| 08.815.104S | In distribution | ||
| 08.815.101S | In distribution | ||
| 08.815.214S | In distribution | ||
| 08.815.173S | In distribution | ||
| 08.815.232S | In distribution | ||
| 08.815.252S | In distribution | ||
| 08.815.334S | In distribution | ||
| 08.815.142S | In distribution | ||
| 08.815.124S | In distribution | ||
| 03.835.432 | In distribution | ||
| 08.815.201S | In distribution | ||
| 08.815.156S | In distribution | ||
| 08.815.225S | In distribution | ||
| 08.815.374S | In distribution | ||
| 08.815.243S | In distribution | ||
| 08.815.145S | In distribution | ||
| 08.815.314S | In distribution | ||
| 08.815.115S | In distribution | ||
| 08.815.342S | In distribution | ||
| 08.815.103S | In distribution | ||
| 08.815.336S | In distribution | ||
| 08.815.106S | In distribution | ||
| 08.815.325S | In distribution | ||
| 08.815.364S | In distribution | ||
| 08.815.155S | In distribution | ||
| 08.815.216S | In distribution | ||
| 08.815.312S | 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
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.