Nile™ Proximal Fixation System
Semi-Adj Transverse Connector Single Slot, Size 28 mm
1manufacturer
13catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | OWI |
| Device type | Bone Fixation Cerclage, Sublaminar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Record published | 2017-06-19 |
| Record revised | 2026-04-20 (version 8) |
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 |
| Sizes | Outer diameter 5.5 to 6 mm; length 10 to 50 mm |
| Distribution end date | 2024-07-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5401-70028A | Length 28 mm | In distribution |
| 5401-70043A | Length 43 mm | In distribution |
| 5401-90020 | In distribution | |
| 5401-75510 | Length 10 mm | In distribution |
| 5401-75058 | Outer Diameter 6 mm | In distribution |
| 5401-74548 | Length 45 mm | In distribution |
| 5401-70034A | Outer Diameter 6 mm | In distribution |
| 5401-70040A | Outer Diameter 6 mm | In distribution |
| 5401-70031A | Length 31 mm | In distribution |
| 5401-74752 | Length 47 mm | In distribution |
| 5401-90029 | In distribution | |
| 5401-70037A | Length 37 mm | In distribution |
| SP-2466 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jazz System | Implanet | 118 |
| Hiline | Globus Medical, Inc. | 22 |
| Ligapass | Medicrea International | 20 |
| Translace™ Spinal Tethering System | Medtronic Sofamor Danek, Inc. | 14 |
| Nile™ Alternative Fixation System | VB Spine LLC | 13 |
| Universal Clamp ™ | Zimmer Spine, Inc. | 9 |
| VersaTie | Nuvasive, Inc. | 8 |
| Silc | Globus Medical, Inc. | 8 |
| Mariner Cap | Seaspine Orthopedics Corporation | 7 |
| Jazz Lock | Implanet | 6 |
| Invictus | Alphatec Spine, Inc. | 5 |
| Karma | Spinal Elements, Inc. | 3 |
Showing 12 of 20. All products under Bone Fixation Cerclage, Sublaminar
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.