Sirion
Llif Implant Trial, Modular, Angled Right
3manufacturers in China registered for this device type
1,465catalogue numbers in this listing
3510(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 | Astura Medical, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-07-14 |
| Record revised | 2025-12-10 (version 4) |
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 |
| Sizes | Width 4 to 26 mm; height 7 to 25 mm; angle 0 to 30 °; length 4 to 65 mm; catheter gauge 9 to 12 Fr; catheter length 200 to 250 mm; guidewire diameter 1.4 mm; guidewire length 320 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GZC10E18C | Width 26 mm | In distribution |
| GA184518C | Length 45 mm | In distribution |
| GZA300000 | In distribution | |
| GA184512D | Length 45 mm | In distribution |
| GZC01B16B | Width 20 mm | In distribution |
| GZC01E02F | Width 26 mm | In distribution |
| GZC01A20A | Width 18 mm | In distribution |
| GZC10C10D | Width 22 mm | In distribution |
| GB224510D | Width 22 mm | In distribution |
| GB265010B | Height 10 mm | In distribution |
| GZC11D02E | Width 24 mm | In distribution |
| GA224014B | Length 40 mm | In distribution |
| GB265520B | Height 20 mm | In distribution |
| GA226512B | Length 65 mm | In distribution |
| GB206012C | Width 20 mm | In distribution |
| GB266018D | Height 18 mm | In distribution |
| GA185016A | Length 50 mm | In distribution |
| GZC10D06F | Width 24 mm | In distribution |
| GZC10E12C | Width 26 mm | In distribution |
| GB265518B | Height 18 mm | In distribution |
| GZC10E18D | Width 26 mm | In distribution |
| GB224014B | Width 22 mm | In distribution |
| GA225512C | Length 55 mm | In distribution |
| GB206018B | Width 20 mm | In distribution |
| GZB25SZ13 | Width 12 mm | In distribution |
| GF1650DFE | Length 50 mm | In distribution |
| GB206507A | Width 20 mm | In distribution |
| GZC10A12D | Width 18 mm | In distribution |
| GZC050000 | In distribution | |
| GA244012B | Length 40 mm | In distribution |
| GZC13A10A | Width 18 mm | In distribution |
| GB224012B | Width 22 mm | In distribution |
| GA266520A | Length 65 mm | In distribution |
| GA184516A | Length 45 mm | In distribution |
| GB265510D | Height 10 mm | In distribution |
| GZC030012 | Width 12 mm | In distribution |
| GZC01A10A | Width 18 mm | In distribution |
| GZB25SZ12 | Width 12 mm | In distribution |
| GZB231018 | Width 10 mm | In distribution |
| GZC01D20D | Width 24 mm | In distribution |
| GB265510B | Height 10 mm | In distribution |
| GA225010D | Length 50 mm | In distribution |
| GB266514C | Height 14 mm | In distribution |
| GA244012A | Length 40 mm | In distribution |
| GZC01A14B | Width 18 mm | In distribution |
| GB206508D | Width 20 mm | In distribution |
| GA225508C | Length 55 mm | In distribution |
| GZC11E06F | Width 26 mm | In distribution |
| GB265520A | Height 20 mm | In distribution |
| GZC10E10G | Width 26 mm | In distribution |
| GA206510A | Length 65 mm | In distribution |
| GA224010D | Length 40 mm | In distribution |
| GA225012C | Length 50 mm | In distribution |
| GZA030000 | Guidewire Diameter 1.4 mm | In distribution |
| GZD120020 | In distribution | |
| GZC10B06F | Width 20 mm | In distribution |
| GA185018B | Length 50 mm | In distribution |
| GA185008A | Length 50 mm | In distribution |
| GZC10C16A | Width 22 mm | In distribution |
| GZC11A18C | Width 18 mm | In distribution |
| GZC11D06G | Width 24 mm | In distribution |
| GZC10B14C | Width 20 mm | In distribution |
| GB266516D | Height 16 mm | In distribution |
| GZC13A20D | Width 18 mm | In distribution |
| GA224510B | Length 45 mm | In distribution |
| GZC13A12D | Width 18 mm | In distribution |
| GZC11B10E | Width 20 mm | In distribution |
| GB266020A | Height 20 mm | In distribution |
| GZC10E08G | Width 26 mm | In distribution |
| GZC11A02F | Width 18 mm | In distribution |
| GB265007B | Height 7 mm | In distribution |
| GZB231022 | Width 10 mm | In distribution |
| GB184018B | Length 40 mm | In distribution |
| GZC11A07C | Width 18 mm | In distribution |
| GZC040040-3 | In distribution | |
| GZC11E02F | Width 26 mm | In distribution |
| GA184518B | Length 45 mm | In distribution |
| GZC01A10E | Width 18 mm | In distribution |
| GZC020009 | Width 9 mm | In distribution |
| GZC11B16A | Width 20 mm | In distribution |
| GB206518D | Width 20 mm | In distribution |
| GB266512D | Height 12 mm | In distribution |
| GA224016D | Length 40 mm | In distribution |
| GB206518C | Width 20 mm | In distribution |
| GZC10A10C | Width 18 mm | In distribution |
| GZC11E08F | Width 26 mm | In distribution |
| GB265512B | Height 12 mm | In distribution |
| GZC10A14B | Width 18 mm | In distribution |
| GZC11B08G | Width 20 mm | In distribution |
| GB206518A | Width 20 mm | In distribution |
| GL1645BBB | Height 8 mm | In distribution |
| GZC10A18D | Width 18 mm | In distribution |
| GZC11B12D | Width 20 mm | In distribution |
| GZC01B04G | Width 20 mm | In distribution |
| GB266007A | Height 7 mm | In distribution |
| GZC01E08A | Width 26 mm | In distribution |
| GZB25AB10 | Width 6 mm | In distribution |
| GA226012A | Length 60 mm | In distribution |
| GB205012D | Width 20 mm | In distribution |
| GB206514B | Width 20 mm | In distribution |
| GZC10A10B | Width 18 mm | In distribution |
| GZC01D18B | Width 24 mm | In distribution |
| GZC11B04E | Width 20 mm | In distribution |
| GZC01B08A | Width 20 mm | In distribution |
| GB205008C | Width 20 mm | In distribution |
| GZC13A10B | Width 18 mm | In distribution |
| GB205018C | Width 20 mm | In distribution |
| GA225016C | Length 50 mm | In distribution |
| GB266010B | Height 10 mm | In distribution |
| GZC11A12B | Width 18 mm | In distribution |
| GZC10B16A | Width 20 mm | In distribution |
| GA184520C | Length 45 mm | In distribution |
| GZC030014 | Width 14 mm | In distribution |
| GB266010A | Height 10 mm | In distribution |
| GB266518B | Height 18 mm | In distribution |
| GA225514C | Length 55 mm | In distribution |
| GB266518A | Height 18 mm | In distribution |
| GA224518B | Length 45 mm | In distribution |
| GA226520D | Length 65 mm | In distribution |
| GZC13B07C | Width 20 mm | In distribution |
| GB224014C | Width 22 mm | In distribution |
| GZC01B18D | Width 20 mm | In distribution |
| GZC01B14B | Width 20 mm | In distribution |
| GB205016A | Width 20 mm | In distribution |
| GB266010C | Height 10 mm | In distribution |
| GB205007A | Length 50 mm | In distribution |
| GZC01A06F | Width 18 mm | In distribution |
| GA224508A | Length 45 mm | In distribution |
| GZC030018 | Width 18 mm | In distribution |
| GB224020D | Width 22 mm | In distribution |
| GB205520A | Width 20 mm | In distribution |
| GA185007B | Length 50 mm | In distribution |
| GZC11A12C | Width 18 mm | In distribution |
| GA225020D | Length 50 mm | In distribution |
| GZC01C12D | Width 22 mm | In distribution |
| GB205516A | Width 20 mm | In distribution |
| GZC10B14D | Width 20 mm | In distribution |
| GZC10E16A | Width 26 mm | In distribution |
| GZC01A16A | Width 18 mm | In distribution |
| GZC10D18D | Width 24 mm | In distribution |
| GA224516D | Length 45 mm | In distribution |
| GA225514B | Length 55 mm | In distribution |
| GZA260R13 | Length 13 mm | In distribution |
| GA184512B | Length 45 mm | In distribution |
| GB206010D | Width 20 mm | In distribution |
| GZB25AB03 | Width 8 mm | In distribution |
| GA185507A | Length 55 mm | In distribution |
| GB224508C | Width 22 mm | In distribution |
| GB224512A | Width 22 mm | In distribution |
| GF1650DFD | Length 50 mm | In distribution |
| GZC01B14A | Width 20 mm | In distribution |
| GZC11B12C | Width 20 mm | In distribution |
| GB205014D | Width 20 mm | In distribution |
| GZC10B02G | Width 20 mm | In distribution |
| GZC01A04E | Width 18 mm | In distribution |
| GZC13A14C | Width 18 mm | In distribution |
| GA224516B | Length 45 mm | In distribution |
| GZA230035 | Length 35 mm | In distribution |
| GA206020D | Length 60 mm | In distribution |
| GZC10D16C | Width 24 mm | In distribution |
| GZC10B04G | Width 20 mm | In distribution |
| GA225016D | Length 50 mm | In distribution |
| GZC13A20B | Width 18 mm | In distribution |
| GA206514C | Length 65 mm | In distribution |
| GA224016B | Length 40 mm | In distribution |
| GA225014D | Length 50 mm | In distribution |
| GZC10B18C | Width 20 mm | In distribution |
| GZC01E12D | Width 26 mm | In distribution |
| GB184012A | Length 40 mm | In distribution |
| GA226508C | Length 65 mm | In distribution |
| GZB25SZ01 | Width 4 mm | In distribution |
| GZC11A14A | Width 18 mm | In distribution |
| GZC10B10B | Width 20 mm | In distribution |
| GZC11B08E | Width 20 mm | In distribution |
| GA184016A | Length 40 mm | In distribution |
| GZC01B20A | Width 20 mm | In distribution |
| GZC10B10C | Width 20 mm | In distribution |
| GF1645FHF | Height 12 mm | In distribution |
| GF1665DFF | Length 65 mm | In distribution |
| GZA250018 | Length 18 mm | In distribution |
| GZC01C04E | Width 22 mm | In distribution |
| GZC01A08C | Width 18 mm | In distribution |
| GZC11C02F | Width 22 mm | In distribution |
| GZC13B14D | Width 20 mm | In distribution |
| GZC01D12D | Width 24 mm | In distribution |
| GA225012B | Length 50 mm | In distribution |
| GA226014A | Length 60 mm | In distribution |
| GZC10B08G | Width 20 mm | In distribution |
| GZC020010 | Width 10 mm | In distribution |
| GA225008C | Length 50 mm | In distribution |
| GZC01D14D | Width 24 mm | In distribution |
| GZC11B16B | Width 20 mm | In distribution |
| GZC01C12A | Width 22 mm | In distribution |
| GF1665DFE | Length 65 mm | In distribution |
| GL1650BBB | Height 8 mm | In distribution |
| GB184008C | Length 40 mm | In distribution |
| GB205507A | Width 20 mm | In distribution |
| GB184018A | Length 40 mm | In distribution |
| GZC030006 | Width 6 mm | In distribution |
| GF1645FHD | Length 65 mm | In distribution |
| GB266514D | Height 14 mm | In distribution |
| GZC01D18D | Width 24 mm | In distribution |
| GZC01D08G | Width 24 mm | In distribution |
| GA206512A | Length 65 mm | In distribution |
| GB224012D | Width 22 mm | In distribution |
| GZC01C08E | Width 22 mm | In distribution |
| GB224012A | Width 22 mm | In distribution |
| GZC10A10D | Width 18 mm | In distribution |
| GZC01A04F | Width 18 mm | In distribution |
| GZC10D04E | Width 24 mm | In distribution |
| GA224507C | Length 45 mm | In distribution |
| GA224510A | Length 45 mm | In distribution |
| GA185012A | Length 50 mm | In distribution |
| GZC01E12C | Width 26 mm | In distribution |
| GZB25SZ02 | Width 6 mm | In distribution |
| GZC11B06G | Width 20 mm | In distribution |
| GZD060000 | In distribution | |
| GZC10C12D | Width 22 mm | In distribution |
| GZC11D10F | Width 24 mm | In distribution |
| GA224020B | Length 40 mm | In distribution |
| GZC090000 | In distribution | |
| GZC10C07B | Width 22 mm | In distribution |
| GZC11A14C | Width 18 mm | In distribution |
| GB206508B | Width 20 mm | In distribution |
| GA225520D | Length 55 mm | In distribution |
| GB265508A | Height 8 mm | In distribution |
| GB206508A | Width 20 mm | In distribution |
| GZC10D18A | Width 24 mm | In distribution |
| GZC01C02F | Width 22 mm | In distribution |
| GA206516A | Length 65 mm | In distribution |
| GB224010B | Width 22 mm | In distribution |
| GZC01E14D | Width 26 mm | In distribution |
| GZC01B10D | Width 20 mm | In distribution |
| GB205014B | Width 20 mm | In distribution |
| GB206008C | Width 20 mm | In distribution |
| GA226014C | Length 60 mm | In distribution |
| GB266518C | Height 18 mm | In distribution |
| GZA260L13 | Length 13 mm | In distribution |
| GZC10D10A | Width 24 mm | In distribution |
| GZB25AB12 | Width 12 mm | In distribution |
| GA225018D | Length 50 mm | In distribution |
| GZB030010 | Catheter Gauge 12 Fr | In distribution |
| GZC10D16D | Width 24 mm | In distribution |
| GB205016C | Width 20 mm | In distribution |
| GZC10E08A | Width 26 mm | In distribution |
| GZA050000 | In distribution | |
| GB205508B | Width 20 mm | In distribution |
| GZC10D07B | Width 24 mm | In distribution |
| GZC10C04E | Width 22 mm | In distribution |
| GZC01D12A | Width 24 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222554 | 2023-01-19 |
| K214047 | 2022-03-30 |
| K192492 | 2020-04-21 |
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.