Durango Stand-Alone Alif System
117 catalogue numbers from 8517-0716, listed by Biomet Spine, United States, under Spinal Vertebral Body Replacement Device. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
117catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2015-10-24 |
| Record revised | 2025-01-03 (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 |
|---|---|---|
| 8517-0716 | ALIF PEEK TI MARKER 7.5° 30X40X16MM | In distribution |
| 8517-0012 | ALIF PEEK Ti Marker 0° 30x40x12mm | In distribution |
| 8511-0718 | ALIF PEEK 7° 24x32x18mm | In distribution |
| 8509-0220 | Full-Plate Ti 20mm | In distribution |
| 8515-0714 | ALIF PEEK Ti Marker 7.5° 27x36x14mm | In distribution |
| 8515-0714 | ALIF PEEK TI MARKER 7.5° 27X36X14MM | In distribution |
| 8524-5030 | Screw Fixed Self-Tap Ti Ø5.0 x 30mm | In distribution |
| 8517-0016 | ALIF PEEK Ti Marker 0° 30x40x16mm | In distribution |
| 8510-4520 | SCREW VAR AGGR-TIP TI Ø4.5 X 20MM | In distribution |
| 8517-1518 | ALIF PEEK TI MARKER 15° 30X40X18MM | In distribution |
| 8510-4540 | Screw Var Aggr-Tip Ti Ø4.5 x 40mm | In distribution |
| 8512-0716 | ALIF PEEK 7° 27X36X16MM | In distribution |
| 8517-1218 | ALIF PEEK Ti Marker 12.5° 30x40x18mm | In distribution |
| 8510-5020 | Screw Var Aggr-Tip Ti Ø5.0 x 20mm | In distribution |
| 8505-0214 | Full-Plate Cover Ti 14mm | In distribution |
| 8515-1520 | ALIF PEEK Ti Marker 15° 27x36x20mm | In distribution |
| 8510-5040 | SCREW VAR AGGR-TIP TI Ø5.0 X 40MM | In distribution |
| 8505-0116 | Half-Plate Cover Ti 16mm | In distribution |
| 8513-0720 | ALIF PEEK TI MARKER 7.5° 24X32X20MM | In distribution |
| 8526-4535 | Screw Variable Self-Tap Ti ø4.5x35mm | In distribution |
| 8511-1520 | ALIF PEEK 15° 24x32x20mm | In distribution |
| 8515-0016 | ALIF PEEK Ti Marker 0° 27x36x16mm | In distribution |
| 8512-1212 | ALIF PEEK 12° 27x36x12mm | In distribution |
| 8505-0012 | ZERO-PLATE COVER TI 12MM | In distribution |
| 8505-0120 | HALF-PLATE COVER TI 20MM | In distribution |
| 8512-0718 | ALIF PEEK 7° 27x36x18mm | In distribution |
| 8505-0112 | HALF-PLATE COVER TI 12MM | In distribution |
| 8513-0018 | ALIF PEEK TI MARKER 0° 24X32X18MM | In distribution |
| 8518-0720 | ALIF PEEK 7° 30x40x20mm | In distribution |
| 8509-0114 | HALF-PLATE TI 14MM | In distribution |
| 8511-0716 | ALIF PEEK 7° 24X32X16MM | In distribution |
| 8524-4525 | Screw Fixed Self-Tap Ti Ø4.5 x 25mm | In distribution |
| 8517-0018 | ALIF PEEK TI MARKER 0° 30X40X18MM | In distribution |
| 8512-1518 | ALIF PEEK 15° 27x36x18mm | In distribution |
| 8517-0018 | ALIF PEEK Ti Marker 0° 30x40x18mm | In distribution |
| 8517-0714 | ALIF PEEK TI MARKER 7.5° 30X40X14MM | In distribution |
| 8515-1218 | ALIF PEEK Ti Marker 12.5° 27x36x18mm | In distribution |
| 8517-0712 | ALIF PEEK Ti Marker 7.5° 30x40x12mm | In distribution |
| 8512-1218 | ALIF PEEK 12° 27x36x18mm | In distribution |
| 8515-1212 | ALIF PEEK TI MARKER 12.5° 27X36X12MM | In distribution |
| 8505-0212 | FULL-PLATE COVER TI 12MM | In distribution |
| 8524-5025 | Screw Fixed Self-Tap Ti Ø5.0 x 25mm | In distribution |
| 8518-0714 | ALIF PEEK 7° 30X40X14MM | In distribution |
| 8513-0716 | ALIF PEEK TI MARKER 7.5° 24X32X16MM | In distribution |
| 8510-5035 | SCREW VAR AGGR-TIP TI Ø5.0 X 35MM | In distribution |
| 8524-4520 | Screw Fixed Self-Tap Ti Ø4.5 x 20mm | In distribution |
| 8517-1216 | ALIF PEEK Ti Marker 12.5° 30x40x16mm | In distribution |
| 8511-1520 | ALIF PEEK 15° 24X32X20MM | In distribution |
| 8515-0716 | ALIF PEEK TI MARKER 7.5° 27X36X16MM | In distribution |
| 8513-1218 | ALIF PEEK TI MARKER 12.5° 24X32X18MM | In distribution |
| 8513-1518 | ALIF PEEK Ti Marker 15° 24x32x18mm | In distribution |
| 8526-4520 | Screw Variable Self-Tap Ti ø4.5x20mm | In distribution |
| 8510-5020 | SCREW VAR AGGR-TIP TI Ø5.0 X 20MM | In distribution |
| 8517-1518 | ALIF PEEK Ti Marker 15° 30x40x18mm | In distribution |
| 8513-1214 | ALIF PEEK TI MARKER 12.5° 24X32X14MM | In distribution |
| 8515-1214 | ALIF PEEK Ti Marker 12.5° 27x36x14mm | In distribution |
| 8518-0712 | ALIF PEEK 7° 30X40X12MM | In distribution |
| 8524-4530 | SCREW FIXED SELF-TAP TI Ø4.5 X 30MM | In distribution |
| 8518-0720 | ALIF PEEK 7° 30X40X20MM | In distribution |
| 8517-1520 | ALIF PEEK Ti Marker 15° 30x40x20mm | In distribution |
| 8505-0218 | FULL-PLATE COVER TI 18MM | In distribution |
| 8526-5040 | Screw Variable Self-Tap Ti ø5.0x40mm | In distribution |
| 8515-0018 | ALIF PEEK Ti Marker 0° 27x36x18mm | In distribution |
| 8517-1214 | ALIF PEEK TI MARKER 12.5° 30X40X14MM | In distribution |
| 8512-0714 | ALIF PEEK 7° 27X36X14MM | In distribution |
| 8518-1518 | ALIF PEEK 15° 30X40X18MM | In distribution |
| 8510-5025 | Screw Var Aggr-Tip Ti Ø5.0 x 25mm | In distribution |
| 8509-0118 | Half-Plate Ti 18mm | In distribution |
| 8511-0018 | ALIF PEEK 0° 24X32X18MM | In distribution |
| 8513-1518 | ALIF PEEK TI MARKER 15° 24X32X18MM | In distribution |
| 8512-1516 | ALIF PEEK 15° 27X36X16MM | In distribution |
| 8509-0018 | Zero-Plate Ti 18mm | In distribution |
| 8509-0116 | Half-Plate Ti 16mm | In distribution |
| 8505-0012 | Zero-Plate Cover Ti 12mm | In distribution |
| 8517-0718 | ALIF PEEK TI MARKER 7.5° 30X40X18MM | In distribution |
| 8518-1512 | ALIF PEEK 15° 30x40x12mm | In distribution |
| 8511-1214 | ALIF PEEK 12° 24X32X14MM | In distribution |
| 8511-1512 | ALIF PEEK 15° 24X32X12MM | In distribution |
| 8526-5035 | SCREW VARIABLE SELF-TAP TI Ø5.0X35MM | In distribution |
| 8515-0020 | ALIF PEEK Ti Marker 0° 27x36x20mm | In distribution |
| 8515-0718 | ALIF PEEK TI MARKER 7.5° 27X36X18MM | In distribution |
| 8515-1220 | ALIF PEEK TI MARKER 12.5° 27X36X20MM | In distribution |
| 8507-4540 | Screw Fixed Aggr-Tip Ti Ø4.5 x 40mm | In distribution |
| 8509-0216 | FULL-PLATE TI 16MM | In distribution |
| 8526-5025 | Screw Variable Self-Tap Ti ø5.0x25mm | In distribution |
| 8512-0020 | ALIF PEEK 0° 27x36x20mm | In distribution |
| 8507-4530 | Screw Fixed Aggr-Tip Ti Ø4.5 x 30mm | In distribution |
| 8518-1512 | ALIF PEEK 15° 30X40X12MM | In distribution |
| 8511-0020 | ALIF PEEK 0° 24X32X20MM | In distribution |
| 8526-4525 | SCREW VARIABLE SELF-TAP TI Ø4.5X25MM | In distribution |
| 8512-1516 | ALIF PEEK 15° 27x36x16mm | In distribution |
| 8518-0018 | ALIF PEEK 0° 30X40X18MM | In distribution |
| 8518-0016 | ALIF PEEK 0° 30X40X16MM | In distribution |
| 8511-1216 | ALIF PEEK 12° 24X32X16MM | In distribution |
| 8515-1214 | ALIF PEEK TI MARKER 12.5° 27X36X14MM | In distribution |
| 8505-0014 | Zero-Plate Cover Ti 14mm | In distribution |
| 8513-0012 | ALIF PEEK Ti Marker 0° 24x32x12mm | In distribution |
| 8517-0716 | ALIF PEEK Ti Marker 7.5° 30x40x16mm | In distribution |
| 8507-4535 | SCREW FIXED AGGR-TIP TI Ø4.5 X 35MM | In distribution |
| 8518-1218 | ALIF PEEK 12° 30x40x18mm | In distribution |
| 8512-1514 | ALIF PEEK 15° 27X36X14MM | In distribution |
| 8517-0718 | ALIF PEEK Ti Marker 7.5° 30x40x18mm | In distribution |
| 8509-0218 | FULL-PLATE TI 18MM | In distribution |
| 8518-0718 | ALIF PEEK 7° 30x40x18mm | In distribution |
| 8505-0112 | Half-Plate Cover Ti 12mm | In distribution |
| 8511-1218 | ALIF PEEK 12° 24X32X18MM | In distribution |
| 8512-0016 | ALIF PEEK 0° 27X36X16MM | In distribution |
| 8513-0712 | ALIF PEEK Ti Marker 7.5° 24x32x12mm | In distribution |
| 8512-0712 | ALIF PEEK 7° 27x36x12mm | In distribution |
| 8518-1218 | ALIF PEEK 12° 30X40X18MM | In distribution |
| 8505-0018 | Zero-Plate Cover Ti 18mm | In distribution |
| 8512-0718 | ALIF PEEK 7° 27X36X18MM | In distribution |
| 8509-0120 | Half-Plate Ti 20mm | In distribution |
| 8517-1212 | ALIF PEEK Ti Marker 12.5° 30x40x12mm | In distribution |
| 8517-1512 | ALIF PEEK TI MARKER 15° 30X40X12MM | In distribution |
| 8505-0220 | FULL-PLATE COVER TI 20MM | In distribution |
| 8512-0714 | ALIF PEEK 7° 27x36x14mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063393 | 2007-06-25 |
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.