Conduit Synfix Evolution
Cage AH 10.5mm 10DEG L
3manufacturers in China registered for this device type
86catalogue 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 | Avalign Technologies, Inc., 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 | Specification developer, Manufacturer |
| Record published | 2025-08-01 |
| Record revised | 2025-08-14 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 431314120 | In distribution | |
| 440325190 | In distribution | |
| 431110170 | In distribution | |
| 431110120 | In distribution | |
| 431310105 | In distribution | |
| 431218170 | In distribution | |
| 431114190 | In distribution | |
| 431214170 | In distribution | |
| 431114150 | In distribution | |
| 432013500 | In distribution | |
| 431206135 | In distribution | |
| 440300001 | In distribution | |
| 431314190 | In distribution | |
| 431306190 | In distribution | |
| 431118170 | In distribution | |
| 431106170 | In distribution | |
| 432015000 | In distribution | |
| 431210150 | In distribution | |
| 431225190 | In distribution | |
| 431306120 | In distribution | |
| 431306135 | In distribution | |
| 431314135 | In distribution | |
| 431106105 | In distribution | |
| 431218190 | In distribution | |
| 431110105 | In distribution | |
| 431130190 | In distribution | |
| 431206170 | In distribution | |
| 431325190 | In distribution | |
| 431118135 | In distribution | |
| 431310135 | In distribution | |
| 431310150 | In distribution | |
| 431110135 | In distribution | |
| 431314150 | In distribution | |
| 440125170 | In distribution | |
| 431210135 | In distribution | |
| 432012000 | In distribution | |
| 431314170 | In distribution | |
| 440225170 | In distribution | |
| 431310190 | In distribution | |
| 440130190 | In distribution | |
| 431230190 | In distribution | |
| 431318190 | In distribution | |
| 431210170 | In distribution | |
| 440125190 | In distribution | |
| 440125150 | In distribution | |
| 431118190 | In distribution | |
| 431206105 | In distribution | |
| 431210105 | In distribution | |
| 440230190 | In distribution | |
| 431214120 | In distribution | |
| 431306170 | In distribution | |
| 431214135 | In distribution | |
| 432019000 | In distribution | |
| 431318170 | In distribution | |
| 431318150 | In distribution | |
| 432017000 | In distribution | |
| 431210120 | In distribution | |
| 431106190 | In distribution | |
| 431214190 | In distribution | |
| 431125150 | In distribution | |
| 432010500 | In distribution | |
| 431206190 | In distribution | |
| 431206120 | In distribution | |
| 431125170 | In distribution | |
| 431106120 | In distribution | |
| 431214150 | In distribution | |
| 431118150 | In distribution | |
| 431114170 | In distribution | |
| 431310120 | In distribution | |
| 431110190 | In distribution | |
| 431114135 | In distribution | |
| 431114120 | In distribution | |
| 431306150 | In distribution | |
| 431106135 | In distribution | |
| 431218135 | In distribution | |
| 431306105 | In distribution | |
| 440225190 | In distribution | |
| 431225170 | In distribution | |
| 431206150 | In distribution | |
| 431218150 | In distribution | |
| 431110150 | In distribution | |
| 431125190 | In distribution | |
| 431318135 | In distribution | |
| 431310170 | In distribution | |
| 431106150 | In distribution | |
| 431210190 | 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 |
|---|---|
| K250072 | 2025-07-10 |
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.