Durango® Stand-Alone Alif System
119 catalogue numbers from 8515-0716, listed by Biomet Spine, United States, under Intervertebral Fusion Device With Bone Graft, Lumbar. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
119catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2020-07-13 |
| 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 |
|---|---|---|
| 8515-0716 | ALIF PEEK Ti Marker 7.5° 27x36x16mm | In distribution |
| 8515-1520 | ALIF PEEK TI MARKER 15° 27X36X20MM | In distribution |
| 8524-5020 | Screw Fixed Self-Tap Ti Ø5.0 x 20mm | In distribution |
| 8517-0714 | ALIF PEEK Ti Marker 7.5° 30x40x14mm | In distribution |
| 8511-0712 | ALIF PEEK 7° 24X32X12MM | In distribution |
| 8510-4535 | SCREW VAR AGGR-TIP TI Ø4.5 X 35MM | In distribution |
| 8517-1512 | ALIF PEEK Ti Marker 15° 30x40x12mm | In distribution |
| 8507-4520 | SCREW FIXED AGGR-TIP TI Ø4.5 X 20MM | In distribution |
| 8515-1516 | ALIF PEEK TI MARKER 15° 27X36X16MM | In distribution |
| 8517-0712 | ALIF PEEK TI MARKER 7.5° 30X40X12MM | In distribution |
| 8512-1220 | ALIF PEEK 12° 27x36x20mm | In distribution |
| 8509-0014 | Zero-Plate Ti 14mm | In distribution |
| 8513-1520 | ALIF PEEK Ti Marker 15° 24x32x20mm | In distribution |
| 8507-5020 | SCREW FIXED AGGR-TIP TI Ø5.0 X 20MM | In distribution |
| 8517-1514 | ALIF PEEK Ti Marker 15° 30x40x14mm | In distribution |
| 8512-1220 | ALIF PEEK 12° 27X36X20MM | In distribution |
| 8526-4520 | SCREW VARIABLE SELF-TAP TI Ø4.5X20MM | In distribution |
| 8518-0012 | ALIF PEEK 0° 30x40x12mm | In distribution |
| 8515-0012 | ALIF PEEK TI MARKER 0° 27X36X12MM | In distribution |
| 8515-1518 | ALIF PEEK TI MARKER 15° 27X36X18MM | In distribution |
| 8509-0012 | ZERO-PLATE TI 12MM | In distribution |
| 8513-0020 | ALIF PEEK Ti Marker 0° 24x32x20mm | In distribution |
| 8517-0012 | ALIF PEEK TI MARKER 0° 30X40X12MM | In distribution |
| 8513-1512 | ALIF PEEK Ti Marker 15° 24x32x12mm | In distribution |
| 8512-1518 | ALIF PEEK 15° 27X36X18MM | In distribution |
| 8517-0016 | ALIF PEEK TI MARKER 0° 30X40X16MM | In distribution |
| 8526-5030 | Screw Variable Self-Tap Ti ø5.0x30mm | In distribution |
| 8513-0720 | ALIF PEEK Ti Marker 7.5° 24x32x20mm | In distribution |
| 8511-1214 | ALIF PEEK 12° 24x32x14mm | In distribution |
| 8511-1220 | ALIF PEEK 12° 24X32X20MM | In distribution |
| 8513-0014 | ALIF PEEK Ti Marker 0° 24x32x14mm | In distribution |
| 8512-1212 | ALIF PEEK 12° 27X36X12MM | In distribution |
| 8513-0016 | ALIF PEEK TI MARKER 0° 24X32X16MM | In distribution |
| 8509-0016 | ZERO-PLATE TI 16MM | In distribution |
| 8510-4525 | Screw Var Aggr-Tip Ti Ø4.5 x 25mm | In distribution |
| 8526-4530 | Screw Variable Self-Tap Ti ø4.5x30mm | In distribution |
| 8515-0016 | ALIF PEEK TI MARKER 0° 27X36X16MM | In distribution |
| 8505-0114 | HALF-PLATE COVER TI 14MM | In distribution |
| 8526-4540 | Screw Variable Self-Tap Ti ø4.5x40mm | In distribution |
| 8517-0020 | ALIF PEEK TI MARKER 0° 30X40X20MM | In distribution |
| 8512-0720 | ALIF PEEK 7° 27X36X20MM | In distribution |
| 8518-0716 | ALIF PEEK 7° 30x40x16mm | In distribution |
| 8515-1512 | ALIF PEEK TI MARKER 15° 27X36X12MM | In distribution |
| 8515-0720 | ALIF PEEK Ti Marker 7.5° 27x36x20mm | In distribution |
| 8517-0720 | ALIF PEEK Ti Marker 7.5° 30x40x20mm | In distribution |
| 8509-0220 | FULL-PLATE TI 20MM | In distribution |
| 8524-4540 | Screw Fixed Self-Tap Ti Ø4.5 x 40mm | In distribution |
| 8507-5040 | Screw Fixed Aggr-Tip Ti Ø5.0 x 40mm | In distribution |
| 8517-0014 | ALIF PEEK Ti Marker 0° 30x40x14mm | In distribution |
| 8517-1514 | ALIF PEEK TI MARKER 15° 30X40X14MM | In distribution |
| 8511-0712 | ALIF PEEK 7° 24x32x12mm | In distribution |
| 8515-0712 | ALIF PEEK Ti Marker 7.5° 27x36x12mm | In distribution |
| 8517-1516 | ALIF PEEK TI MARKER 15° 30X40X16MM | In distribution |
| 8517-1214 | ALIF PEEK Ti Marker 12.5° 30x40x14mm | In distribution |
| 8507-5035 | Screw Fixed Aggr-Tip Ti Ø5.0 x 35mm | In distribution |
| 8507-4540 | SCREW FIXED AGGR-TIP TI Ø4.5 X 40MM | In distribution |
| 8513-0020 | ALIF PEEK TI MARKER 0° 24X32X20MM | In distribution |
| 8518-1214 | ALIF PEEK 12° 30X40X14MM | In distribution |
| 8505-0216 | FULL-PLATE COVER TI 16MM | In distribution |
| 8513-0714 | ALIF PEEK TI MARKER 7.5° 24X32X14MM | In distribution |
| 8505-0020 | Zero-Plate Cover Ti 20mm | In distribution |
| 8507-5030 | Screw Fixed Aggr-Tip Ti Ø5.0 x 30mm | In distribution |
| 8511-0714 | ALIF PEEK 7° 24x32x14mm | In distribution |
| 8505-0020 | ZERO-PLATE COVER TI 20MM | In distribution |
| 8513-0014 | ALIF PEEK TI MARKER 0° 24X32X14MM | In distribution |
| 8515-0018 | ALIF PEEK TI MARKER 0° 27X36X18MM | In distribution |
| 8515-1218 | ALIF PEEK TI MARKER 12.5° 27X36X18MM | In distribution |
| 8507-5025 | SCREW FIXED AGGR-TIP TI Ø5.0 X 25MM | In distribution |
| 8507-4530 | SCREW FIXED AGGR-TIP TI Ø4.5 X 30MM | In distribution |
| 8510-5040 | Screw Var Aggr-Tip Ti Ø5.0 x 40mm | In distribution |
| 8515-0712 | ALIF PEEK TI MARKER 7.5° 27X36X12MM | In distribution |
| 8524-5040 | Screw Fixed Self-Tap Ti Ø5.0 x 40mm | In distribution |
| 8515-0720 | ALIF PEEK TI MARKER 7.5° 27X36X20MM | In distribution |
| 8518-1220 | ALIF PEEK 12° 30X40X20MM | In distribution |
| 8518-1212 | ALIF PEEK 12° 30x40x12mm | In distribution |
| 8512-1216 | ALIF PEEK 12° 27x36x16mm | In distribution |
| 8505-0220 | Full-Plate Cover Ti 20mm | In distribution |
| 8512-1214 | ALIF PEEK 12° 27x36x14mm | In distribution |
| 8513-1514 | ALIF PEEK TI MARKER 15° 24X32X14MM | In distribution |
| 8513-0012 | ALIF PEEK TI MARKER 0° 24X32X12MM | In distribution |
| 8518-0712 | ALIF PEEK 7° 30x40x12mm | In distribution |
| 8518-0716 | ALIF PEEK 7° 30X40X16MM | In distribution |
| 8513-1218 | ALIF PEEK Ti Marker 12.5° 24x32x18mm | In distribution |
| 8515-1216 | ALIF PEEK TI MARKER 12.5° 27X36X16MM | In distribution |
| 8511-0014 | ALIF PEEK 0° 24x32x14mm | In distribution |
| 8513-1212 | ALIF PEEK Ti Marker 12.5° 24x32x12mm | In distribution |
| 8513-0718 | ALIF PEEK TI MARKER 7.5° 24X32X18MM | In distribution |
| 8505-0118 | Half-Plate Cover Ti 18mm | In distribution |
| 8515-1514 | ALIF PEEK Ti Marker 15° 27x36x14mm | In distribution |
| 8507-5035 | SCREW FIXED AGGR-TIP TI Ø5.0 X 35MM | In distribution |
| 8505-0016 | ZERO-PLATE COVER TI 16MM | In distribution |
| 8517-0014 | ALIF PEEK TI MARKER 0° 30X40X14MM | In distribution |
| 8517-1216 | ALIF PEEK TI MARKER 12.5° 30X40X16MM | In distribution |
| 8524-4530 | Screw Fixed Self-Tap Ti Ø4.5 x 30mm | In distribution |
| 8511-1218 | ALIF PEEK 12° 24x32x18mm | In distribution |
| 8510-5030 | SCREW VAR AGGR-TIP TI Ø5.0 X 30MM | In distribution |
| 8510-4530 | Screw Var Aggr-Tip Ti Ø4.5 x 30mm | In distribution |
| 8517-1220 | ALIF PEEK Ti Marker 12.5° 30x40x20mm | In distribution |
| 8518-1214 | ALIF PEEK 12° 30x40x14mm | In distribution |
| 8515-1220 | ALIF PEEK Ti Marker 12.5° 27x36x20mm | In distribution |
| 8507-5025 | Screw Fixed Aggr-Tip Ti Ø5.0 x 25mm | In distribution |
| 8518-0718 | ALIF PEEK 7° 30X40X18MM | In distribution |
| 8507-4520 | Screw Fixed Aggr-Tip Ti Ø4.5 x 20mm | In distribution |
| 8511-0020 | ALIF PEEK 0° 24x32x20mm | In distribution |
| 8510-4520 | Screw Var Aggr-Tip Ti Ø4.5 x 20mm | In distribution |
| 8526-4525 | Screw Variable Self-Tap Ti ø4.5x25mm | In distribution |
| 8526-5040 | SCREW VARIABLE SELF-TAP TI Ø5.0X40MM | In distribution |
| 8511-0716 | ALIF PEEK 7° 24x32x16mm | In distribution |
| 8515-1216 | ALIF PEEK Ti Marker 12.5° 27x36x16mm | In distribution |
| 8515-0020 | ALIF PEEK TI MARKER 0° 27X36X20MM | In distribution |
| 8505-0118 | HALF-PLATE COVER TI 18MM | In distribution |
| 8512-0014 | ALIF PEEK 0° 27X36X14MM | In distribution |
| 8515-1212 | ALIF PEEK Ti Marker 12.5° 27x36x12mm | In distribution |
| 8513-0718 | ALIF PEEK Ti Marker 7.5° 24x32x18mm | In distribution |
| 8517-1218 | ALIF PEEK TI MARKER 12.5° 30X40X18MM | In distribution |
| 8513-1216 | ALIF PEEK Ti Marker 12.5° 24x32x16mm | In distribution |
| 8524-4520 | SCREW FIXED SELF-TAP TI Ø4.5 X 20MM | In distribution |
| 8505-0014 | ZERO-PLATE COVER TI 14MM | In distribution |
| 8515-0014 | ALIF PEEK TI MARKER 0° 27X36X14MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153695 | 2016-01-21 |
| K151483 | 2015-07-31 |
| K142634 | 2015-03-12 |
| K112014 | 2011-10-17 |
| K081636 | 2008-08-07 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.