Virata
ROD, MIS, PRECONTOURED, Ti, 6.0mm x 160mm
11manufacturers in China registered for this device type
477catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K250908 |
| Record published | 2026-06-19 |
| Record revised | 2025-10-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TL1-50260050 | In distribution | |
| TL1-50055180 | In distribution | |
| TL1-50255180 | In distribution | |
| TL3-00000021 | In distribution | |
| TL1-30015110 | In distribution | |
| TL1-30180030 | In distribution | |
| TL1-50060180 | In distribution | |
| TL1-30155075 | In distribution | |
| TL1-30080020 | In distribution | |
| TL1-10770055 | In distribution | |
| TL1-30165045 | In distribution | |
| TL1-50360160 | In distribution | |
| TL1-50060110 | In distribution | |
| TL1-50460070 | In distribution | |
| TL1-10780060 | In distribution | |
| TL1-50360090 | In distribution | |
| TL1-50455070 | In distribution | |
| TL3-20000023 | In distribution | |
| TL1-30280040 | In distribution | |
| TL1-30060070 | In distribution | |
| TL1-30065030 | In distribution | |
| TL1-30080110 | In distribution | |
| TL1-50455100 | In distribution | |
| TL1-50255080 | In distribution | |
| TL1-30055030 | In distribution | |
| TL1-30090040 | In distribution | |
| TL1-50060055 | In distribution | |
| TL1-50355070 | In distribution | |
| TL1-50055100 | In distribution | |
| TL1-30155095 | In distribution | |
| TL1-50155180 | In distribution | |
| TL1-50060090 | In distribution | |
| TL1-50355150 | In distribution | |
| TL1-50360130 | In distribution | |
| TL1-50155090 | In distribution | |
| TL1-30060095 | In distribution | |
| TL1-30280045 | In distribution | |
| TL1-30255025 | In distribution | |
| TL1-30050045 | In distribution | |
| TL1-30080050 | In distribution | |
| TL1-30075095 | In distribution | |
| TL3-00000004 | In distribution | |
| TL1-50160170 | In distribution | |
| TL1-30085065 | In distribution | |
| TL1-50455090 | In distribution | |
| TL1-50460170 | In distribution | |
| TL1-30265045 | In distribution | |
| TL1-30010045 | In distribution | |
| TL1-30060035 | In distribution | |
| TL1-30265055 | In distribution | |
| TL1-30065095 | In distribution | |
| TL1-30180060 | In distribution | |
| TL1-10775025 | In distribution | |
| TL1-50455130 | In distribution | |
| TL1-50355055 | In distribution | |
| TL1-50060075 | In distribution | |
| TL1-30175085 | In distribution | |
| TL1-30180075 | In distribution | |
| TL1-50255050 | In distribution | |
| TL1-30080060 | In distribution | |
| TL1-30175095 | In distribution | |
| TL1-10770040 | In distribution | |
| TL1-50055045 | In distribution | |
| TL1-30010055 | In distribution | |
| TL1-50455350 | In distribution | |
| TL1-50255045 | In distribution | |
| TL3-00000020 | In distribution | |
| TL1-50055075 | In distribution | |
| TL1-50260055 | In distribution | |
| TL1-50255400 | In distribution | |
| TL1-50460100 | In distribution | |
| TL1-30070020 | In distribution | |
| TL1-30060025 | In distribution | |
| TL1-30165035 | In distribution | |
| TL1-50255250 | In distribution | |
| TL1-30025100 | In distribution | |
| TL1-30095040 | In distribution | |
| TL1-10760025 | In distribution | |
| TL1-50460180 | In distribution | |
| TL1-50355180 | In distribution | |
| TL1-30170050 | In distribution | |
| TL1-30080065 | In distribution | |
| TL1-30160085 | In distribution | |
| TL1-50160070 | In distribution | |
| TL1-50455095 | In distribution | |
| TL1-30280030 | In distribution | |
| TL1-30150035 | In distribution | |
| TL1-50155140 | In distribution | |
| TL1-30085030 | In distribution | |
| TL1-30250060 | In distribution | |
| TL1-50455110 | In distribution | |
| TL1-50060300 | In distribution | |
| TL1-50160160 | In distribution | |
| TL1-30180045 | In distribution | |
| TL1-30055020 | In distribution | |
| TL1-30020045 | In distribution | |
| TL1-30050050 | In distribution | |
| TL1-50460115 | In distribution | |
| TL1-50055115 | In distribution | |
| TL1-30025050 | In distribution | |
| TL3-10000009 | In distribution | |
| TL1-30025060 | In distribution | |
| TL1-50355140 | In distribution | |
| TL1-50060045 | In distribution | |
| TL1-50055025 | In distribution | |
| TL1-50460500 | In distribution | |
| TL1-30085100 | In distribution | |
| TL1-30065100 | In distribution | |
| TL1-50360125 | In distribution | |
| TL3-10000006 | In distribution | |
| TL1-50155050 | In distribution | |
| TL1-30285040 | In distribution | |
| TL1-30060050 | In distribution | |
| TL3-10000017 | In distribution | |
| TL1-50460030 | In distribution | |
| TL1-30175035 | In distribution | |
| TL1-30060090 | In distribution | |
| TL1-10780045 | In distribution | |
| TL1-50460190 | In distribution | |
| TL1-50060600 | In distribution | |
| TL1-30080040 | In distribution | |
| TL1-30280050 | In distribution | |
| TL1-50255300 | In distribution | |
| TL3-00000003 | In distribution | |
| TL1-50055105 | In distribution | |
| TL1-30185085 | In distribution | |
| TL1-50455065 | In distribution | |
| TL1-30085040 | In distribution | |
| TL1-30015030 | In distribution | |
| TL1-30275035 | In distribution | |
| TL1-30070095 | In distribution | |
| TL1-50060065 | In distribution | |
| TL1-30160100 | In distribution | |
| TL1-30090095 | In distribution | |
| TL1-30020055 | In distribution | |
| TL1-10780055 | In distribution | |
| TL1-30185095 | In distribution | |
| TL1-30175070 | In distribution | |
| TL1-50055095 | In distribution | |
| TL1-10780030 | In distribution | |
| TL1-50455300 | In distribution | |
| TL1-50260085 | In distribution | |
| TL1-50055150 | In distribution | |
| TL1-50460075 | In distribution | |
| TL1-30260035 | In distribution | |
| TL1-50255500 | In distribution | |
| TL1-30260050 | In distribution | |
| TL1-30280060 | In distribution | |
| TL1-50255035 | In distribution | |
| TL1-10755025 | In distribution | |
| TL1-50060025 | In distribution | |
| TL1-50360030 | In distribution | |
| TL1-50055065 | In distribution | |
| TL1-30090050 | In distribution | |
| TL1-30090065 | In distribution | |
| TL1-30010100 | In distribution | |
| TL1-30011095 | In distribution | |
| TL1-50155120 | In distribution | |
| TL1-50255040 | In distribution | |
| TL1-10775060 | In distribution | |
| TL3-00000011 | In distribution | |
| TL1-50055300 | In distribution | |
| TL1-30095045 | In distribution | |
| TL1-30055050 | In distribution | |
| TL1-50255170 | In distribution | |
| TL1-30260045 | In distribution | |
| TL1-50160080 | In distribution | |
| TL1-30165075 | In distribution | |
| TL1-30260055 | In distribution | |
| TL1-30065025 | In distribution | |
| TL1-30011070 | In distribution | |
| TL1-30270060 | In distribution | |
| TL1-50455075 | In distribution | |
| TL1-30165055 | In distribution | |
| TL1-50355160 | In distribution | |
| TL1-30285060 | In distribution | |
| TL1-30020090 | In distribution | |
| TL1-50455045 | In distribution | |
| TL1-30015085 | In distribution | |
| TL1-30285035 | In distribution | |
| TL1-30050035 | In distribution | |
| TL1-30155120 | In distribution | |
| TL1-30175060 | In distribution | |
| TL1-30060085 | In distribution | |
| TL3-00000002 | In distribution | |
| TL3-00000008 | In distribution | |
| TL1-50055250 | In distribution | |
| TL1-30265050 | In distribution | |
| TL1-50160115 | In distribution | |
| TL1-50355115 | In distribution | |
| TL1-10755055 | In distribution | |
| TL1-30070090 | In distribution | |
| TL1-30065055 | In distribution | |
| TL1-10750050 | In distribution | |
| TL3-20000013 | In distribution | |
| TL1-50060150 | In distribution | |
| TL1-50160075 | In distribution | |
| TL1-30175075 | In distribution | |
| TL1-30010080 | In distribution | |
| TL1-30160055 | In distribution | |
| TL1-50455050 | In distribution | |
| TL3-10000001 | In distribution | |
| TL1-30180070 | In distribution | |
| TL1-30090060 | In distribution | |
| TL1-50255065 | In distribution | |
| TL3-00000013 | In distribution | |
| TL1-50255070 | In distribution | |
| TL1-10750035 | In distribution | |
| TL1-50355080 | In distribution | |
| TL1-30065065 | In distribution | |
| TL1-50355190 | In distribution | |
| TL1-50055200 | In distribution | |
| TL1-50460300 | In distribution | |
| TL1-30170045 | In distribution | |
| TL1-30070075 | In distribution | |
| TL1-50455200 | In distribution | |
| TL1-00000000 | In distribution | |
| TL1-30170110 | In distribution | |
| TL1-50255030 | In distribution | |
| TL1-30095065 | In distribution | |
| TL1-30050025 | In distribution | |
| TL3-10000008 | In distribution | |
| TL1-30155070 | In distribution | |
| TL3-00000019 | In distribution | |
| TL1-50060105 | In distribution | |
| TL1-50360095 | In distribution | |
| TL1-30265060 | In distribution | |
| TL1-30010090 | In distribution | |
| TL1-30065090 | In distribution | |
| TL1-10765030 | In distribution | |
| TL3-10000014 | In distribution | |
| TL1-30050055 | In distribution | |
| TL1-50360045 | In distribution | |
| TL1-30055055 | In distribution | |
| TL1-50255350 | In distribution | |
| TL1-50255025 | In distribution | |
| TL1-50060085 | In distribution | |
| TL1-30080090 | In distribution | |
| TL1-50455180 | In distribution | |
| TL1-30025090 | In distribution | |
| TL1-50460400 | In distribution | |
| TL1-30080120 | In distribution | |
| TL1-30080030 | In distribution | |
| TL1-30160030 | In distribution | |
| TL1-50355045 | In distribution | |
| TL1-50160025 | In distribution | |
| TL1-30085060 | In distribution | |
| TL3-10000016 | In distribution | |
| TL1-30060030 | In distribution | |
| TL1-10775055 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Orthofix US LLC | 510(k) number | 2025-09-19 | Class II | Process change control | Polyaxial screws do not meet performance standards. | 624 units |
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.