Idys™- Alif
Idys ALIF is an anterior lumbar interbody fusion system using a PEEK cage, titanium-alloy plate and four fixation screws. The cage contains two slots for autologous bone graft and is…
Idys ALIF is an anterior lumbar interbody fusion system using a PEEK cage, titanium-alloy plate and four fixation screws. The cage contains two slots for autologous bone graft and is connected to the plate for standalone implantation.
Teeth on the upper and lower cage surfaces engage the vertebral endplates and resist back-out. Tantalum markers allow cage position to be checked with radiographic imaging.
Listed Item
SET Screw Final Tightener
Graft and Configurations
The cage uses PEEK OPTIMA LT1 and is available in different footprints, heights and lordotic angles. It is intended for one or two adjacent levels from L2 to S1 in skeletally mature patients, with autograft and the integrated fixation screws supplied for the system.
3manufacturers in China registered for this device type
138catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Clariance, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172083 |
| Record published | 2018-02-15 |
| Record revised | 2025-12-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Width 26 to 40 mm; height 10 to 1818 mm; depth 24 to 32 mm; angle 6 to 18 °; length 20 to 440 mm; outer diameter 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24713006 | Width 40 mm | In distribution |
| 24706012 | Height 12 mm | In distribution |
| 24523610-S | Height 1610 mm | In distribution |
| 24010520-S | Length 20 mm | In distribution |
| 24020540-S | Length 40 mm | In distribution |
| 24020535-S | Length 32 mm | In distribution |
| 24711006 | Depth 30 mm | In distribution |
| 24520006-S | Width 32 mm | In distribution |
| 24710418 | Angle 18 ° | In distribution |
| 24521818-S | Height 1818 mm | In distribution |
| 24717040 | Depth 30 mm | In distribution |
| 24713010 | Depth 30 mm | In distribution |
| 24721001 | Depth 30 mm | In distribution |
| 24712010 | Width 26 mm | In distribution |
| 24710814 | Angle 14 ° | In distribution |
| 24713410 | Depth 30 mm | In distribution |
| 24713610 | Width 40 mm | In distribution |
| 24520206-S | Width 32 mm | In distribution |
| 24521618-S | Height 1618 mm | In distribution |
| 24523814-S | Width 40 mm | In distribution |
| 24523818-S | Height 1818 mm | In distribution |
| 24712206 | Depth 24 mm | In distribution |
| 24521006-S | Height 1006 mm | In distribution |
| 24523206-S | Height 1206 mm | In distribution |
| 24522418-S | Height 1418 mm | In distribution |
| 24712214 | Depth 24 mm | In distribution |
| 24523410-S | Width 40 mm | In distribution |
| 24522214-S | Width 26 mm | In distribution |
| 24761035 | Depth 30 mm | In distribution |
| 24010535-S | Outer Diameter 5 mm | In distribution |
| 24712418 | Width 26 mm | In distribution |
| 24711214 | Depth 30 mm | In distribution |
| 24520814-S | Height 1814 mm | In distribution |
| 24520410-S | Height 1410 mm | In distribution |
| 24520214-S | Width 32 mm | In distribution |
| 24712614 | Width 26 mm | In distribution |
| 24521614-S | Width 35 mm | In distribution |
| 24521610-S | Height 1610 mm | In distribution |
| 24712210 | Width 26 mm | In distribution |
| 24520418-S | Height 1418 mm | In distribution |
| 24713206 | Width 40 mm | In distribution |
| 24520614-S | Height 1614 mm | In distribution |
| 24521010-S | Width 35 mm | In distribution |
| 24711410 | Width 35 mm | In distribution |
| 24713214 | Width 40 mm | In distribution |
| 24521414-S | Height 1414 mm | In distribution |
| 24710614 | Angle 14 ° | In distribution |
| 24706018 | Height 18 mm | In distribution |
| 24713210 | Depth 30 mm | In distribution |
| 24710006 | Angle 6 ° | In distribution |
| 24711814 | Depth 30 mm | In distribution |
| 24430010-S | Height 10 mm | In distribution |
| 24712410 | Width 26 mm | In distribution |
| 24715001 | Length 440 mm | In distribution |
| 24520414-S | Width 32 mm | In distribution |
| 24522618-S | Width 26 mm | In distribution |
| 24711206 | Depth 30 mm | In distribution |
| 24020555-S | Length 55 mm | In distribution |
| 24710214 | Angle 14 ° | In distribution |
| 24711614 | Depth 30 mm | In distribution |
| 24522010-S | Height 1010 mm | In distribution |
| 24020545-S | Length 45 mm | In distribution |
| 24523006-S | Height 1006 mm | In distribution |
| 24761026 | Width 26 mm | In distribution |
| 24522006-S | Width 26 mm | In distribution |
| 24710610 | Angle 10 ° | In distribution |
| 24710010 | Angle 10 ° | In distribution |
| 24717032 | Depth 32 mm | In distribution |
| 24523418-S | Width 40 mm | In distribution |
| 24430018-S | Height 18 mm | In distribution |
| 24523210-S | Width 40 mm | In distribution |
| 24710818 | Angle 18 ° | In distribution |
| 24520610-S | Width 32 mm | In distribution |
| 24712618 | Depth 24 mm | In distribution |
| 24521214-S | Height 1214 mm | In distribution |
| 24522410-S | Height 1410 mm | In distribution |
| 24010525-S | Outer Diameter 5 mm | In distribution |
| 24720001 | Width 40 mm | In distribution |
| 24710414 | Angle 14 ° | In distribution |
| 24712818 | Depth 24 mm | In distribution |
| 24713418 | Depth 30 mm | In distribution |
| 24520010-S | Height 1010 mm | In distribution |
| 24710206 | Angle 6 ° | In distribution |
| 24711414 | Depth 30 mm | In distribution |
| 24717026 | Width 26 mm | In distribution |
| 24711818 | Width 35 mm | In distribution |
| 24522818-S | Width 26 mm | In distribution |
| 24713414 | Width 40 mm | In distribution |
| 24522414-S | Width 26 mm | In distribution |
| 24711618 | Width 35 mm | In distribution |
| 24522210-S | Height 1210 mm | In distribution |
| 24521206-S | Height 1206 mm | In distribution |
| 24523214-S | Height 1214 mm | In distribution |
| 24713814 | Depth 30 mm | In distribution |
| 24430016-S | Height 16 mm | In distribution |
| 24712414 | Depth 24 mm | In distribution |
| 24521418-S | Width 35 mm | In distribution |
| 24523010-S | Width 40 mm | In distribution |
| 24430014-S | Height 14 mm | In distribution |
| 24711610 | Height 16 mm | In distribution |
| 24522206-S | Width 26 mm | In distribution |
| 24706010 | Height 10 mm | In distribution |
| 24712006 | Depth 24 mm | In distribution |
| 24761032 | Depth 26 mm | In distribution |
| 24520618-S | Width 32 mm | In distribution |
| 24762001 | In distribution | |
| 24706016 | Height 16 mm | In distribution |
| 24761040 | Depth 30 mm | In distribution |
| 24717035 | Width 35 mm | In distribution |
| 24720005 | In distribution | |
| 24711418 | Width 35 mm | In distribution |
| 24523414-S | Height 1414 mm | In distribution |
| 24521814-S | Width 35 mm | In distribution |
| 24520818-S | Width 32 mm | In distribution |
| 24715002 | Length 440 mm | In distribution |
| 24430012-S | Height 12 mm | In distribution |
| 24522814-S | Height 1814 mm | In distribution |
| 24521210-S | Width 35 mm | In distribution |
| 24711010 | Width 35 mm | In distribution |
| 24522614-S | Height 1614 mm | In distribution |
| 24523614-S | Width 40 mm | In distribution |
| 24711210 | Width 35 mm | In distribution |
| 24521410-S | Width 35 mm | In distribution |
| 24520210-S | Height 1210 mm | In distribution |
| 24712610 | Depth 24 mm | In distribution |
| 24716000 | Length 440 mm | In distribution |
| 24713618 | Width 40 mm | In distribution |
| 24713818 | Width 40 mm | In distribution |
| 24523618-S | Height 1618 mm | In distribution |
| 24710618 | Angle 14 ° | In distribution |
| 24706014 | Height 14 mm | In distribution |
| 24710210 | Angle 10 ° | In distribution |
| 24010530-S | Length 30 mm | In distribution |
| 24522610-S | Width 26 mm | In distribution |
| 24710410 | Angle 10 ° | In distribution |
| 24713614 | Depth 30 mm | In distribution |
| 24020550-S | Length 50 mm | In distribution |
| 24712814 | Width 26 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| 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 |
|---|---|
| K202032 | 2021-04-01 |
| K192168 | 2019-11-04 |
| K191263 | 2019-06-06 |
| K172083 | 2017-11-08 |
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.