Idys®-ALIF TiVac
Idys ALIF TiVac is a lumbar interbody fusion system combining a PEEK cage with a titanium alloy plate and four bone screws. The integrated plate-and-screw construct permits standalone use…
Idys ALIF TiVac is a lumbar interbody fusion system combining a PEEK cage with a titanium alloy plate and four bone screws. The integrated plate-and-screw construct permits standalone use within the specified applications.
The cage has titanium-coated upper and lower surfaces with teeth that engage the vertebral endplates. Two graft slots hold the patient’s own bone graft, while tantalum markers show the implant position on radiographs.
Listed Item
Alif Cage
Material and Placement
The cage body is PEEK-Optima LT1, with plasma-sprayed titanium on the bone-facing surfaces. The plate and screws are Ti-6Al-4V alloy. The system is intended for one- or two-level anterior lumbar fusion from L2 to S1 and is supplied sterile for single use.
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) | K191263 |
| Record published | 2019-12-14 |
| Record revised | 2025-12-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 10 to 18 mm; depth 24 to 30 mm; angle 6 to 18 °; width 26 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42523414-S | Height 14 mm | In distribution |
| 42523410-S | Depth 30 mm | In distribution |
| 42523210-S | Height 12 mm | In distribution |
| 42520210-S | Width 32 mm | In distribution |
| 42520206-S | Depth 26 mm | In distribution |
| 42520610-S | Height 16 mm | In distribution |
| 42521418-S | Height 14 mm | In distribution |
| 42523418-S | Angle 18 ° | In distribution |
| 42523818-S | Depth 30 mm | In distribution |
| 42523814-S | Angle 14 ° | In distribution |
| 42520010-S | Depth 26 mm | In distribution |
| 42522618-S | Depth 24 mm | In distribution |
| 42523010-S | Angle 10 ° | In distribution |
| 42522010-S | Height 10 mm | In distribution |
| 42523618-S | Height 16 mm | In distribution |
| 42520410-S | Angle 10 ° | In distribution |
| 42521214-S | Depth 30 mm | In distribution |
| 42520214-S | Depth 26 mm | In distribution |
| 42520618-S | Height 16 mm | In distribution |
| 42522814-S | Depth 24 mm | In distribution |
| 42521010-S | Angle 10 ° | In distribution |
| 42521614-S | Depth 30 mm | In distribution |
| 42521414-S | Width 35 mm | In distribution |
| 42521210-S | Width 35 mm | In distribution |
| 42520006-S | Depth 26 mm | In distribution |
| 42521610-S | Width 35 mm | In distribution |
| 42522006-S | Depth 24 mm | In distribution |
| 42521814-S | Width 35 mm | In distribution |
| 42522614-S | Depth 24 mm | In distribution |
| 42522210-S | Height 12 mm | In distribution |
| 42520814-S | Height 18 mm | In distribution |
| 42521206-S | Angle 6 ° | In distribution |
| 42522410-S | Depth 24 mm | In distribution |
| 42523006-S | Angle 6 ° | In distribution |
| 42520818-S | Depth 26 mm | In distribution |
| 42523614-S | Angle 14 ° | In distribution |
| 42520614-S | Height 16 mm | In distribution |
| 42522206-S | Width 26 mm | In distribution |
| 42522414-S | Width 26 mm | In distribution |
| 42523610-S | Height 16 mm | In distribution |
| 42522418-S | Angle 18 ° | In distribution |
| 42522610-S | Depth 24 mm | In distribution |
| 42521818-S | Width 35 mm | In distribution |
| 42523206-S | Angle 6 ° | In distribution |
| 42520414-S | Width 32 mm | In distribution |
| 42521006-S | Height 10 mm | In distribution |
| 42522214-S | Depth 24 mm | In distribution |
| 42520418-S | Depth 26 mm | In distribution |
| 42521410-S | Height 14 mm | In distribution |
| 42521618-S | Angle 18 ° | In distribution |
| 42522818-S | Width 26 mm | In distribution |
| 42523214-S | Width 40 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.