SynFix-LR
Synfix(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM Height 12DEG-STER
3manufacturers in China registered for this device type
18catalogue 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 (U.S.A.) LP |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K072253 |
| Record published | 2015-09-14 |
| Record revised | 2025-07-02 (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 |
| Distribution end date | 2021-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.802.212 | Withdrawn | |
| 08.802.004S | Withdrawn | |
| 08.802.012S | Withdrawn | |
| 08.802.014S | Withdrawn | |
| 08.802.002S | Withdrawn | |
| 04.802.211 | Withdrawn | |
| 08.802.009S | Withdrawn | |
| 08.802.003S | Withdrawn | |
| 08.802.017S | Withdrawn | |
| 08.802.016S | Withdrawn | |
| 04.802.210 | Withdrawn | |
| 08.802.018S | Withdrawn | |
| 08.802.007S | Withdrawn | |
| 08.802.019S | Withdrawn | |
| 08.802.010S | Withdrawn | |
| 04.802.213 | Withdrawn | |
| 08.802.005S | Withdrawn | |
| 04.802.202 | Withdrawn |
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.