Dakota Alif System
Dakota ALIF is an anterior lumbar interbody system combining a PEEK cage with integrated titanium alloy screws. The cage provides mechanical support during fusion and is used with autograft…
Dakota ALIF is an anterior lumbar interbody system combining a PEEK cage with integrated titanium alloy screws. The cage provides mechanical support during fusion and is used with autograft bone.
Tantalum markers provide the cage’s radiographic reference. Screw-backout prevention plates accompany the integrated fixation screws, while cage width, height and lordotic angle vary to accommodate anatomy.
Listed Item
Large Standalone Cage Implant & Trial Kit – 39 & 42mm x 15° & 20°
Fixation by Angle
The standard construct is intended as a stand-alone system using its supplied bone screws. Hyperlordotic implants at 20 degrees or more require additional supplemental lumbar fixation. This distinction separates integrated fixation from the extra support required by higher-angle cages.
3manufacturers in China registered for this device type
300catalogue numbers in this listing
1510(k) clearance
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 | Precision Spine, Inc., United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer |
| 510(k) | K213118 |
| Record published | 2022-01-25 |
| Record revised | 2025-03-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-07-14 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 69-AL-2515 | In distribution | |
| 69-SC-1320 | In distribution | |
| 69-AG-0811 | In distribution | |
| 69-AV-0011 | In distribution | |
| 69-AS-2517 | In distribution | |
| 69-BK-0402 | In distribution | |
| 69-BK-1215 | In distribution | |
| 69-BK-1620 | In distribution | |
| 69-AG-2015 | In distribution | |
| 69-AV-0019 | In distribution | |
| 69-AL-0817 | In distribution | |
| 69-BK-1225 | In distribution | |
| 69-BK-3000 | In distribution | |
| 69-AM-0819 | In distribution | |
| 69-AG-0819 | In distribution | |
| 69-AV-2517 | In distribution | |
| 69-SC-1925 | In distribution | |
| 69-AS-0819 | In distribution | |
| 69-AM-0011 | In distribution | |
| 69-BK-1308 | In distribution | |
| 69-AM-0815-2C | In distribution | |
| 69-AG-0017 | In distribution | |
| 69-AV-1515 | In distribution | |
| 69-AS-0011 | In distribution | |
| 69-AS-2017 | In distribution | |
| 69-AG-2519 | In distribution | |
| 69-AV-0817 | In distribution | |
| 69-SC-1920 | In distribution | |
| 69-AG-1517 | In distribution | |
| 69-AV-0015 | In distribution | |
| 69-AS-0817 | In distribution | |
| 69-AM-1519 | In distribution | |
| 69-AS-1517 | In distribution | |
| 69-AL-0011 | In distribution | |
| 69-AG-1513 | In distribution | |
| 69-AG-1511 | In distribution | |
| 69-SC-7000 | In distribution | |
| 69-SC-0400 | In distribution | |
| 69-AV-0815 | In distribution | |
| 69-AM-0813 | In distribution | |
| 69-BK-1908 | In distribution | |
| 69-AV-0017 | In distribution | |
| 69-SC-1215 | In distribution | |
| 69-AG-2517 | In distribution | |
| 69-SC-1015 | In distribution | |
| 69-AV-0813 | In distribution | |
| 69-AM-2013 | In distribution | |
| 69-AM-3019 | In distribution | |
| 69-AG-0013 | In distribution | |
| 69-AM-0815 | In distribution | |
| 69-AV-3019 | In distribution | |
| 69-AM-2017 | In distribution | |
| 69-AL-3017 | In distribution | |
| 69-SC-1208 | In distribution | |
| 69-AS-0815 | In distribution | |
| 69-BK-1315 | In distribution | |
| 69-AV-2019 | In distribution | |
| 69-AM-2515 | In distribution | |
| 69-BK-1325 | In distribution | |
| 69-SC-1008 | In distribution | |
| 69-AM-1515 | In distribution | |
| 69-AL-1519 | In distribution | |
| 69-AL-2517 | In distribution | |
| 69-AG-2515 | In distribution | |
| 69-SC-0200 | In distribution | |
| 69-AS-1515 | In distribution | |
| 69-AL-0815 | In distribution | |
| 69-AV-2015 | In distribution | |
| 69-AG-2019 | In distribution | |
| 69-AL-0819 | In distribution | |
| 69-SC-1220 | In distribution | |
| 69-SC-1020 | In distribution | |
| 69-AL-1511 | In distribution | |
| 69-AL-0813 | In distribution | |
| 69-SC-1620 | In distribution | |
| 69-AM-2019 | In distribution | |
| 69-AM-0015 | In distribution | |
| 69-AS-2013 | In distribution | |
| 69-AM-3017 | In distribution | |
| 69-SC-0500 | In distribution | |
| 69-AG-1511-2C | In distribution | |
| 69-AV-0013 | In distribution | |
| 69-SC-1625 | In distribution | |
| 69-AV-1519 | In distribution | |
| 69-AS-3019 | In distribution | |
| 69-AL-0019 | In distribution | |
| 69-AM-0013 | In distribution | |
| 69-AM-0811 | In distribution | |
| 69-AL-1515 | In distribution | |
| 69-BK-1625 | In distribution | |
| 69-BK-0104 | In distribution | |
| 69-BK-1020 | In distribution | |
| 69-BK-1220 | In distribution | |
| 69-SC-1025 | In distribution | |
| 69-AG-0015 | In distribution | |
| 69-AS-0813 | In distribution | |
| 69-AV-3017 | In distribution | |
| 69-AS-2015 | In distribution | |
| 69-BK-0401 | In distribution | |
| 69-BK-0404 | In distribution | |
| 69-BK-1320 | In distribution | |
| 69-AS-0019 | In distribution | |
| 69-BK-0105 | In distribution | |
| 69-BK-7000 | In distribution | |
| 69-AG-3017 | In distribution | |
| 69-SC-3000 | In distribution | |
| 69-BK-6000 | In distribution | |
| 69-SC-1615 | In distribution | |
| 69-AS-2515 | In distribution | |
| 69-AL-2013 | In distribution | |
| 69-SC-1308 | In distribution | |
| 69-AS-2019 | In distribution | |
| 69-AS-0017 | In distribution | |
| 69-SC-1908 | In distribution | |
| 69-AS-0013 | In distribution | |
| 69-AL-2015 | In distribution | |
| 69-AL-0015 | In distribution | |
| 69-AG-0813 | In distribution | |
| 69-AG-0019 | In distribution | |
| 69-BK-1208 | In distribution | |
| 69-AG-0815 | In distribution | |
| 69-AG-2017 | In distribution | |
| 69-AL-2019 | In distribution | |
| 69-AS-1511 | In distribution | |
| 69-BK-1615 | In distribution | |
| 69-AV-2515 | In distribution | |
| 69-AM-2015 | In distribution | |
| 69-SC-6000 | In distribution | |
| 69-SC-1325 | In distribution | |
| 69-AL-0017 | In distribution | |
| 69-AL-3019 | In distribution | |
| 69-SC-0600 | In distribution | |
| 69-AS-0015 | In distribution | |
| 69-AM-1517 | In distribution | |
| 69-BK-1915 | In distribution | |
| 69-AV-1517 | In distribution | |
| 69-BK-1925 | In distribution | |
| 69-SC-0100 | In distribution | |
| 69-AL-1513 | In distribution | |
| 69-AS-2519 | In distribution | |
| 69-AL-1517 | In distribution | |
| 69-AM-1513 | In distribution | |
| 69-AM-1511 | In distribution | |
| 69-AS-1519 | In distribution | |
| 69-BK-0600 | In distribution | |
| 69-BK-1025 | In distribution | |
| 69-AG-1515 | In distribution | |
| 69-AV-0819 | In distribution | |
| 69-AM-2517 | In distribution | |
| 69-SC-1315 | In distribution | |
| 69-BK-0102 | In distribution | |
| 69-SC-1608 | In distribution | |
| 69-AS-1513 | In distribution | |
| 69-AV-1511 | In distribution | |
| 69-AL-2017 | In distribution | |
| 69-BK-1608 | In distribution | |
| 69-BK-0500 | In distribution | |
| 69-AV-1513 | In distribution | |
| 69-AG-2015-2C | In distribution | |
| 69-AS-0811 | In distribution | |
| 69-SC-1225 | In distribution | |
| 69-AL-2519 | In distribution | |
| 69-BK-0103 | In distribution | |
| 69-AS-3017 | In distribution | |
| 69-AV-2013 | In distribution | |
| 69-AV-0811 | In distribution | |
| 69-BK-1920 | In distribution | |
| 69-AV-2017 | In distribution | |
| 69-AG-2013 | In distribution | |
| 69-AM-0019 | In distribution | |
| 69-AV-2519 | In distribution | |
| 69-AS-2517-2C | In distribution | |
| 69-AG-0817 | In distribution | |
| 69-BK-1008 | In distribution | |
| 69-SC-1915 | In distribution | |
| 69-AM-0817 | In distribution | |
| 69-AG-0011 | In distribution | |
| 69-AL-0013 | In distribution | |
| 69-AM-0017 | In distribution | |
| 69-BK-1015 | In distribution | |
| 69-AM-2519 | In distribution | |
| 69-AG-1519 | In distribution | |
| 69-BK-0101 | In distribution | |
| 69-AL-0811 | In distribution | |
| 69-BK-0200 | In distribution | |
| 69-AV-2519-2C | Withdrawn | |
| 69-AV-1511-2C | Withdrawn | |
| 69-AM-2019-2C | Withdrawn | |
| 69-AM-2015-2C | Withdrawn | |
| 69-AG-0811-2C | Withdrawn | |
| 69-AL-2017-2C | Withdrawn | |
| 69-AV-0815-2C | Withdrawn | |
| 69-AG-0015-2C | Withdrawn | |
| 69-AL-0811-2C | Withdrawn | |
| 69-AM-1515-2C | Withdrawn | |
| 69-AS-0013-2C | Withdrawn | |
| 69-AG-0817-2C | Withdrawn | |
| 69-AM-0013-2C | Withdrawn | |
| 69-AM-2013-2C | Withdrawn | |
| 69-AL-0017-2C | Withdrawn | |
| 69-AG-1517-2C | Withdrawn | |
| 69-AV-0011-2C | Withdrawn | |
| 69-AM-2515-2C | Withdrawn | |
| 69-AV-2515-2C | Withdrawn | |
| 69-AS-3017-2C | Withdrawn | |
| 69-AM-0817-2C | Withdrawn | |
| 69-AS-1519-2C | Withdrawn | |
| 69-AL-1517-2C | Withdrawn | |
| 69-AM-1517-2C | Withdrawn | |
| 69-AV-2017-2C | Withdrawn | |
| 69-AM-1513-2C | Withdrawn | |
| 69-AV-1515-2C | Withdrawn | |
| 69-AM-0019-2C | Withdrawn | |
| 69-AS-2015-2C | Withdrawn | |
| 69-AG-0011-2C | Withdrawn | |
| 69-AL-3019-2C | Withdrawn | |
| 69-AS-2019-2C | Withdrawn | |
| 69-AM-1511-2C | Withdrawn | |
| 69-AL-2519-2C | Withdrawn | |
| 69-AM-0015-2C | Withdrawn | |
| 69-AL-2517-2C | Withdrawn | |
| 69-AM-0811-2C | Withdrawn | |
| 69-AS-0819-2C | Withdrawn | |
| 69-AG-1515-2C | Withdrawn | |
| 69-AG-2515-2C | Withdrawn | |
| 69-AS-0811-2C | Withdrawn | |
| 69-AM-2519-2C | Withdrawn | |
| 69-AV-0817-2C | Withdrawn | |
| 69-AL-0013-2C | Withdrawn | |
| 69-AV-3019-2C | Withdrawn | |
| 69-AL-1515-2C | Withdrawn | |
| 69-AS-2013-2C | Withdrawn | |
| 69-AG-2519-2C | Withdrawn | |
| 69-AM-0813-2C | Withdrawn | |
| 69-AS-3019-2C | Withdrawn | |
| 69-AS-0015-2C | Withdrawn | |
| 69-AM-2517-2C | Withdrawn | |
| 69-AL-2013-2C | Withdrawn | |
| 69-AG-0017-2C | Withdrawn | |
| 69-AG-0813-2C | Withdrawn | |
| 69-AL-1513-2C | Withdrawn | |
| 69-AM-0011-2C | Withdrawn | |
| 69-AG-3019-2C | Withdrawn | |
| 69-AS-2017-2C | Withdrawn | |
| 69-AL-3017-2C | Withdrawn | |
| 69-AS-0817-2C | Withdrawn | |
| 69-AV-0013-2C | Withdrawn | |
| 69-AG-1519-2C | Withdrawn | |
| 69-AG-2517-2C | Withdrawn | |
| 69-AV-0019-2C | Withdrawn |
Showing 250 of 300 catalogue numbers.
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| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213118 | 2022-04-01 |
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.