Idys®-ALIF 3DTi
Cage ALIF 3DTi
3manufacturers in China registered for this device type
54catalogue 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) | K200919 |
| Record published | 2021-07-05 |
| Record revised | 2025-07-14 (version 2) |
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 |
| Sizes | Height 10 to 18 mm; angle 6 to 18 °; depth 24 to 30 mm; width 26 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 46572206-S | Height 12 mm | In distribution |
| 46570818-S | Height 18 mm | In distribution |
| 46573210-S | Depth 30 mm | In distribution |
| 46573418-S | Depth 30 mm | In distribution |
| 46571610-S | Width 35 mm | In distribution |
| 46573814-S | Width 40 mm | In distribution |
| 46570206-S | Width 32 mm | In distribution |
| 46571010-S | Width 35 mm | In distribution |
| 46572210-S | Angle 10 ° | In distribution |
| 46573610-S | Width 40 mm | In distribution |
| 46571410-S | Height 14 mm | In distribution |
| 46570614-S | Height 16 mm | In distribution |
| 46571814-S | Height 18 mm | In distribution |
| 46572410-S | Height 14 mm | In distribution |
| 46572818-S | Depth 24 mm | In distribution |
| 46571210-S | Angle 10 ° | In distribution |
| 46572610-S | Angle 10 ° | In distribution |
| 46573414-S | Angle 14 ° | In distribution |
| 46572006-S | Depth 24 mm | In distribution |
| 46571214-S | Height 12 mm | In distribution |
| 46570410-S | Height 14 mm | In distribution |
| 46572414-S | Depth 24 mm | In distribution |
| 46570814-S | Angle 14 ° | In distribution |
| 46571618-S | Depth 30 mm | In distribution |
| 46573614-S | Height 16 mm | In distribution |
| 46571818-S | Height 18 mm | In distribution |
| 46570006-S | Height 10 mm | In distribution |
| 46572010-S | Height 10 mm | In distribution |
| 46571206-S | Depth 30 mm | In distribution |
| 46570618-S | Height 16 mm | In distribution |
| 46571414-S | Depth 30 mm | In distribution |
| 46571614-S | Angle 14 ° | In distribution |
| 46572814-S | Height 18 mm | In distribution |
| 46573206-S | Height 12 mm | In distribution |
| 46572614-S | Depth 24 mm | In distribution |
| 46573818-S | Depth 30 mm | In distribution |
| 46573410-S | Angle 10 ° | In distribution |
| 46761000 | In distribution | |
| 46571418-S | Height 14 mm | In distribution |
| 46573618-S | Depth 30 mm | In distribution |
| 46570210-S | Angle 10 ° | In distribution |
| 46761001 | In distribution | |
| 46570214-S | Angle 14 ° | In distribution |
| 46572418-S | Width 26 mm | In distribution |
| 46571006-S | Width 35 mm | In distribution |
| 46572214-S | Angle 14 ° | In distribution |
| 46570418-S | Width 32 mm | In distribution |
| 46570414-S | Angle 14 ° | In distribution |
| 46573010-S | Angle 10 ° | In distribution |
| 46570610-S | Depth 26 mm | In distribution |
| 46573214-S | Depth 30 mm | In distribution |
| 46572618-S | Height 16 mm | In distribution |
| 46570010-S | Height 10 mm | In distribution |
| 46573006-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.