Kyocera Medical Technologies, Inc.
Ti-6Al-4V ALIF Implant 38 X 30, 13mm Height 17° Hyperlordotic
3manufacturers in China registered for this device type
345catalogue 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 | Kyocera Medical Technologies, 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K180502 |
| Record published | 2019-01-17 |
| Record revised | 2025-07-14 (version 8) |
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 |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | 2 | In distribution | |
| PEEK SA ALIF | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| S 128 | 2 | In distribution | |
| S 128 | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| S 128 | 2 | In distribution | |
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | 2 | In distribution | |
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| S 128 | 2 | In distribution | |
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | 2 | In distribution | |
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | 2 | In distribution | |
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-K XL | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | 2 | In distribution | |
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| S 128 | 2 | In distribution | |
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| S 128 | 2 | In distribution | |
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | 2 | In distribution | |
| S 128 | In distribution | ||
| PEEK SA ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| Tesera-k PL | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | In distribution | ||
| Tesera | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | 2 | In distribution | |
| Tesera-k ALIF | In distribution | ||
| Tesera | In distribution | ||
| S 128 | In distribution | ||
| S 128 | In distribution | ||
| Tesera-k ALIF | In distribution | ||
| S 128 | 2 | In distribution | |
| S 128 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
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|---|---|---|
| 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 |
|---|---|
| K261353 | 2026-07-15 |
| K230808 | 2023-04-21 |
| K212980 | 2022-01-07 |
| K193320 | 2020-02-04 |
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.