Durango Stand-Alone Alif System
99 catalogue numbers from 8510-4525, listed by Biomet Spine, United States, under Intervertebral Fusion Device With Bone Graft, Cervical. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
99catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 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 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-02 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8510-4525 | SCREW VAR AGGR-TIP TI Ø4.5 X 25MM | In distribution |
| 8509-0016 | Zero-Plate Ti 16mm | In distribution |
| 8505-0114 | Half-Plate Cover Ti 14mm | In distribution |
| 8512-1514 | ALIF PEEK 15° 27x36x14mm | In distribution |
| 8526-5020 | SCREW VARIABLE SELF-TAP TI Ø5.0X20MM | In distribution |
| 8526-5025 | SCREW VARIABLE SELF-TAP TI Ø5.0X25MM | In distribution |
| 8510-4540 | SCREW VAR AGGR-TIP TI Ø4.5 X 40MM | In distribution |
| 8505-0218 | Full-Plate Cover Ti 18mm | In distribution |
| 8513-0016 | ALIF PEEK Ti Marker 0° 24x32x16mm | In distribution |
| 8518-0714 | ALIF PEEK 7° 30x40x14mm | In distribution |
| 8507-5020 | Screw Fixed Aggr-Tip Ti Ø5.0 x 20mm | In distribution |
| 8513-0714 | ALIF PEEK Ti Marker 7.5° 24x32x14mm | In distribution |
| 8517-1516 | ALIF PEEK Ti Marker 15° 30x40x16mm | In distribution |
| 8526-4530 | SCREW VARIABLE SELF-TAP TI Ø4.5X30MM | In distribution |
| 8511-1512 | ALIF PEEK 15° 24x32x12mm | In distribution |
| 8518-1212 | ALIF PEEK 12° 30X40X12MM | In distribution |
| 8512-1512 | ALIF PEEK 15° 27X36X12MM | In distribution |
| 8507-4535 | Screw Fixed Aggr-Tip Ti Ø4.5 x 35mm | In distribution |
| 8517-0020 | ALIF PEEK Ti Marker 0° 30x40x20mm | In distribution |
| 8511-0714 | ALIF PEEK 7° 24X32X14MM | In distribution |
| 8510-5030 | Screw Var Aggr-Tip Ti Ø5.0 x 30mm | In distribution |
| 8518-1516 | ALIF PEEK 15° 30X40X16MM | In distribution |
| 8526-5030 | SCREW VARIABLE SELF-TAP TI Ø5.0X30MM | In distribution |
| 8513-0716 | ALIF PEEK Ti Marker 7.5° 24x32x16mm | In distribution |
| 8513-1214 | ALIF PEEK Ti Marker 12.5° 24x32x14mm | In distribution |
| 8505-0120 | Half-Plate Cover Ti 20mm | In distribution |
| 8511-1516 | ALIF PEEK 15° 24X32X16MM | In distribution |
| 8518-1216 | ALIF PEEK 12° 30x40x16mm | In distribution |
| 8509-0112 | HALF-PLATE TI 12MM | In distribution |
| 8515-1516 | ALIF PEEK Ti Marker 15° 27x36x16mm | In distribution |
| 8510-5025 | SCREW VAR AGGR-TIP TI Ø5.0 X 25MM | In distribution |
| 8511-0018 | ALIF PEEK 0° 24x32x18mm | In distribution |
| 8513-0712 | ALIF PEEK TI MARKER 7.5° 24X32X12MM | In distribution |
| 8526-4540 | SCREW VARIABLE SELF-TAP TI Ø4.5X40MM | In distribution |
| 8518-1516 | ALIF PEEK 15° 30x40x16mm | In distribution |
| 8511-0016 | ALIF PEEK 0° 24X32X16MM | In distribution |
| 8511-1216 | ALIF PEEK 12° 24x32x16mm | In distribution |
| 8513-1514 | ALIF PEEK Ti Marker 15° 24x32x14mm | In distribution |
| 8512-0018 | ALIF PEEK 0° 27x36x18mm | In distribution |
| 8518-1518 | ALIF PEEK 15° 30x40x18mm | In distribution |
| 8513-1516 | ALIF PEEK Ti Marker 15° 24x32x16mm | In distribution |
| 8515-1512 | ALIF PEEK Ti Marker 15° 27x36x12mm | In distribution |
| 8517-1212 | ALIF PEEK TI MARKER 12.5° 30X40X12MM | In distribution |
| 8509-0020 | Zero-Plate Ti 20mm | In distribution |
| 8505-0214 | FULL-PLATE COVER TI 14MM | In distribution |
| 8515-1518 | ALIF PEEK Ti Marker 15° 27x36x18mm | In distribution |
| 8524-4535 | Screw Fixed Self-Tap Ti Ø4.5 x 35mm | In distribution |
| 8526-5035 | Screw Variable Self-Tap Ti ø5.0x35mm | In distribution |
| 8511-1514 | ALIF PEEK 15° 24x32x14mm | In distribution |
| 8511-0012 | ALIF PEEK 0° 24x32x12mm | In distribution |
| 8505-0016 | Zero-Plate Cover Ti 16mm | In distribution |
| 8511-0720 | ALIF PEEK 7° 24X32X20MM | In distribution |
| 8515-0012 | ALIF PEEK Ti Marker 0° 27x36x12mm | In distribution |
| 8509-0012 | Zero-Plate Ti 12mm | In distribution |
| 8524-5035 | Screw Fixed Self-Tap Ti Ø5.0 x 35mm | In distribution |
| 8505-0018 | ZERO-PLATE COVER TI 18MM | In distribution |
| 8509-0212 | Full-Plate Ti 12mm | In distribution |
| 8524-5025 | SCREW FIXED SELF-TAP TI Ø5.0 X 25MM | In distribution |
| 8513-0018 | ALIF PEEK Ti Marker 0° 24x32x18mm | In distribution |
| 8507-4525 | Screw Fixed Aggr-Tip Ti Ø4.5 x 25mm | In distribution |
| 8509-0216 | Full-Plate Ti 16mm | In distribution |
| 8510-5035 | Screw Var Aggr-Tip Ti Ø5.0 x 35mm | In distribution |
| 8509-0112 | Half-Plate Ti 12mm | In distribution |
| 8518-1520 | ALIF PEEK 15° 30x40x20mm | In distribution |
| 8513-1220 | ALIF PEEK Ti Marker 12.5° 24x32x20mm | In distribution |
| 8512-0716 | ALIF PEEK 7° 27x36x16mm | In distribution |
| 8518-1514 | ALIF PEEK 15° 30x40x14mm | In distribution |
| 8511-0720 | ALIF PEEK 7° 24x32x20mm | In distribution |
| 8517-1520 | ALIF PEEK TI MARKER 15° 30X40X20MM | In distribution |
| 8512-0712 | ALIF PEEK 7° 27X36X12MM | In distribution |
| 8510-4530 | SCREW VAR AGGR-TIP TI Ø4.5 X 30MM | In distribution |
| 8512-0012 | ALIF PEEK 0° 27X36X12MM | In distribution |
| 8513-1512 | ALIF PEEK TI MARKER 15° 24X32X12MM | In distribution |
| 8513-1220 | ALIF PEEK TI MARKER 12.5° 24X32X20MM | In distribution |
| 8515-0014 | ALIF PEEK Ti Marker 0° 27x36x14mm | In distribution |
| 8512-1512 | ALIF PEEK 15° 27x36x12mm | In distribution |
| 8518-0016 | ALIF PEEK 0° 30x40x16mm | In distribution |
| 8507-5040 | SCREW FIXED AGGR-TIP TI Ø5.0 X 40MM | In distribution |
| 8507-4525 | SCREW FIXED AGGR-TIP TI Ø4.5 X 25MM | In distribution |
| 8509-0014 | ZERO-PLATE TI 14MM | In distribution |
| 8511-1212 | ALIF PEEK 12° 24x32x12mm | In distribution |
| 8515-1514 | ALIF PEEK TI MARKER 15° 27X36X14MM | In distribution |
| 8515-0718 | ALIF PEEK Ti Marker 7.5° 27x36x18mm | In distribution |
| 8510-4535 | Screw Var Aggr-Tip Ti Ø4.5 x 35mm | In distribution |
| 8513-1212 | ALIF PEEK TI MARKER 12.5° 24X32X12MM | In distribution |
| 8505-0212 | Full-Plate Cover Ti 12mm | In distribution |
| 8507-5030 | SCREW FIXED AGGR-TIP TI Ø5.0 X 30MM | In distribution |
| 8511-0016 | ALIF PEEK 0° 24x32x16mm | In distribution |
| 8518-0012 | ALIF PEEK 0° 30X40X12MM | In distribution |
| 8511-1220 | ALIF PEEK 12° 24x32x20mm | In distribution |
| 8513-1520 | ALIF PEEK TI MARKER 15° 24X32X20MM | In distribution |
| 8505-0116 | HALF-PLATE COVER TI 16MM | In distribution |
| 8518-0014 | ALIF PEEK 0° 30X40X14MM | In distribution |
| 8511-1514 | ALIF PEEK 15° 24X32X14MM | In distribution |
| 8513-1516 | ALIF PEEK TI MARKER 15° 24X32X16MM | In distribution |
| 8517-1220 | ALIF PEEK TI MARKER 12.5° 30X40X20MM | In distribution |
| 8505-0216 | Full-Plate Cover Ti 16mm | In distribution |
| 8513-1216 | ALIF PEEK TI MARKER 12.5° 24X32X16MM | In distribution |
| 8517-0720 | ALIF PEEK TI MARKER 7.5° 30X40X20MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
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.