Sirion
Llif CUP Curette, Angled, High, Cranial, Serrated
14manufacturers in China registered for this device type
1,246catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Astura Medical, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-07-13 |
| Record revised | 2025-12-10 (version 6) |
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 | Length 4 to 210 mm; width 4 to 24 mm; height 7 to 20 mm; angle 0 to 30 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GZB14AC03 | 3 | In distribution |
| GA244020D | Length 40 mm | In distribution |
| GL1655FHC | Width 16 mm | In distribution |
| GZB13SG06 | 6 | In distribution |
| GZB18AA18 | Length 18 mm | In distribution |
| GZB09SZ26 | Length 26 mm | In distribution |
| GZB13S104 | 4 | In distribution |
| GZB24SZ06 | Width 6 mm | In distribution |
| GA244518C | Length 45 mm | In distribution |
| GDDAA5540 | Length 40 mm | In distribution |
| GZA08A100 | Length 100 mm | In distribution |
| GB186018B | Length 60 mm | In distribution |
| GDDBB6035 | Length 35 mm | In distribution |
| GZB15AF07 | 7 | In distribution |
| GB204020B | Length 40 mm | In distribution |
| GDDBB6050 | Length 50 mm | In distribution |
| GB186510D | Length 65 mm | In distribution |
| GM1645FHE | Length 45 mm | In distribution |
| GZB13S002 | 2 | In distribution |
| GZB13AN06 | 6 | In distribution |
| GZB15AD06 | 6 | In distribution |
| GM1645FHF | Length 45 mm | In distribution |
| GA205508A | Length 55 mm | In distribution |
| GZA07A120 | Length 120 mm | In distribution |
| GB186008D | Length 60 mm | In distribution |
| GB186018D | Length 60 mm | In distribution |
| GZB13SP05 | 5 | In distribution |
| GA204012B | Angle 7 ° | In distribution |
| GCDBBZZ20 | Length 20 mm | In distribution |
| GZA11R110 | Length 110 mm | In distribution |
| GZB10SZ04 | Length 4 mm | In distribution |
| GB204512A | Length 45 mm | In distribution |
| GZB13SY01 | 1 | In distribution |
| GZB15S303 | 3 | In distribution |
| GZA08C120 | Length 120 mm | In distribution |
| GZB17AF08 | Length 8 mm | In distribution |
| GZB14AD02 | 2 | In distribution |
| GZB09AF24 | Length 24 mm | In distribution |
| GZA07F130 | Length 130 mm | In distribution |
| GZB13ST05 | 5 | In distribution |
| GM1645FHG | Length 45 mm | In distribution |
| GZB14AE03 | 3 | In distribution |
| GZA07D120 | Length 120 mm | In distribution |
| GZA11L140 | Length 140 mm | In distribution |
| GA204012A | Angle 0 ° | In distribution |
| GB204514A | Length 45 mm | In distribution |
| GZE080000 | In distribution | |
| GZB16SR14 | Length 14 mm | In distribution |
| GA204518D | Angle 15 ° | In distribution |
| GB204016A | Length 40 mm | In distribution |
| GZA07A180 | Length 180 mm | In distribution |
| GB204520A | Length 45 mm | In distribution |
| GZB17AD14 | Length 14 mm | In distribution |
| GZB09AC22 | Length 22 mm | In distribution |
| GZB14AE06 | 6 | In distribution |
| GZB18AB28 | Length 28 mm | In distribution |
| GCDABZZ22 | Length 22 mm | In distribution |
| GM1660FHE | Length 60 mm | In distribution |
| GZA08B150 | Length 150 mm | In distribution |
| GZB13SV01 | 1 | In distribution |
| GZA07D100 | Length 100 mm | In distribution |
| GZA08C190 | Length 190 mm | In distribution |
| GB185508B | Length 55 mm | In distribution |
| GA246008B | Length 60 mm | In distribution |
| GA206016D | Length 60 mm | In distribution |
| GZB17AE08 | Length 8 mm | In distribution |
| GB185018D | Length 50 mm | In distribution |
| GZA07D090 | Length 90 mm | In distribution |
| GB185507B | Length 55 mm | In distribution |
| GA245507A | Length 55 mm | In distribution |
| GA204010B | Angle 7 ° | In distribution |
| GZB16AC22 | Length 22 mm | In distribution |
| GA245520B | Length 55 mm | In distribution |
| GZB13AM04 | 4 | In distribution |
| GZB17AD18 | Length 18 mm | In distribution |
| GB185012C | Length 50 mm | In distribution |
| GZB18AB24 | Length 24 mm | In distribution |
| GZA08B130 | Length 130 mm | In distribution |
| GZA07A130 | Length 130 mm | In distribution |
| GA244516B | Length 45 mm | In distribution |
| GA204520B | Angle 7 ° | In distribution |
| GZB15AE02 | 2 | In distribution |
| GA244520D | Length 45 mm | In distribution |
| GZA08B160 | Length 160 mm | In distribution |
| GA205012A | Length 50 mm | In distribution |
| GB204507B | Length 45 mm | In distribution |
| GZA090010 | Width 8 mm | In distribution |
| GZA08C080 | Length 80 mm | In distribution |
| GA204010A | Angle 0 ° | In distribution |
| GB186512B | Length 65 mm | In distribution |
| GB186016C | Length 60 mm | In distribution |
| GCDAAZZ20 | Length 20 mm | In distribution |
| GZB16AE24 | Length 24 mm | In distribution |
| GZB15AE05 | 5 | In distribution |
| GZB13AD02 | 2 | In distribution |
| GZB09AF10 | Length 10 mm | In distribution |
| GCDABZZ16 | Length 16 mm | In distribution |
| GZA08C095 | Length 95 mm | In distribution |
| GB186518D | Length 65 mm | In distribution |
| GA204510C | Angle 12 ° | In distribution |
| GZB13SZ05 | 5 | In distribution |
| GDDBA5545 | Length 45 mm | In distribution |
| GA205007C | Length 50 mm | In distribution |
| GZA07A080 | Length 80 mm | In distribution |
| GB186510A | Length 65 mm | In distribution |
| GA204508A | Angle 0 ° | In distribution |
| GZB13SU02 | 2 | In distribution |
| GZB13AD06 | 6 | In distribution |
| GB186516B | Length 65 mm | In distribution |
| GZB13SW06 | 6 | In distribution |
| GZB15SZ07 | 7 | In distribution |
| GA244514C | Length 45 mm | In distribution |
| GA245518B | Length 55 mm | In distribution |
| GA244518A | Length 45 mm | In distribution |
| GZB16AF16 | Length 16 mm | In distribution |
| GZB11AN06 | 6 | In distribution |
| GB204520D | Length 45 mm | In distribution |
| GB186010B | Length 60 mm | In distribution |
| GB186020C | Length 60 mm | In distribution |
| GA205008A | Length 50 mm | In distribution |
| GM1660BDD | Length 60 mm | In distribution |
| GZB13AK02 | 2 | In distribution |
| GZB13AD05 | 5 | In distribution |
| GDDAB6040 | Length 40 mm | In distribution |
| GZB12AF04 | 4 | In distribution |
| GB204516A | Length 45 mm | In distribution |
| GM1655FHF | Length 55 mm | In distribution |
| GZB14SZ05 | 5 | In distribution |
| GZA07D180 | Length 180 mm | In distribution |
| GZB14AF02 | 2 | In distribution |
| GA204020C | Angle 12 ° | In distribution |
| GB185510A | Length 55 mm | In distribution |
| GZA07E085 | Length 85 mm | In distribution |
| GA244518D | Length 45 mm | In distribution |
| GB204012A | Length 40 mm | In distribution |
| GA206008A | Length 60 mm | In distribution |
| GA245020A | Length 50 mm | In distribution |
| GZB13S102 | 2 | In distribution |
| GZA11R120 | Length 120 mm | In distribution |
| GB204507A | Length 45 mm | In distribution |
| GZB15S204 | 4 | In distribution |
| GA206012C | Length 60 mm | In distribution |
| GZA07D110 | Length 110 mm | In distribution |
| GCDAAZZ12 | Length 12 mm | In distribution |
| GB185007C | Length 50 mm | In distribution |
| GZA07F210 | Length 210 mm | In distribution |
| GZB09AE20 | Length 20 mm | In distribution |
| GA205020A | Length 50 mm | In distribution |
| GZA07B140 | Length 140 mm | In distribution |
| GZA11L090 | Length 90 mm | In distribution |
| GA205512C | Length 55 mm | In distribution |
| GZB17AD08 | Length 8 mm | In distribution |
| GZB18AB12 | Length 12 mm | In distribution |
| GZB15AD08 | 8 | In distribution |
| GM1665BBD | Width 16 mm | In distribution |
| GB186014B | Length 60 mm | In distribution |
| GZA07C180 | Length 180 mm | In distribution |
| GZA08A160 | Length 160 mm | In distribution |
| GZA07A170 | Length 170 mm | In distribution |
| GZA11R090 | Length 90 mm | In distribution |
| GDDBB6030 | Length 30 mm | In distribution |
| GA245512D | Length 55 mm | In distribution |
| GZB13AN03 | 3 | In distribution |
| GCDCAZZ10 | Length 10 mm | In distribution |
| GCDAAZZ08 | Length 8 mm | In distribution |
| GZEA45FHC | Width 16 mm | In distribution |
| GZB18AB22 | Length 22 mm | In distribution |
| GA204508B | Angle 7 ° | In distribution |
| GZB15SZ08 | 8 | In distribution |
| GA205520C | Length 55 mm | In distribution |
| GB186008A | Length 60 mm | In distribution |
| GZB09AF30 | Length 30 mm | In distribution |
| GZB13SW01 | 1 | In distribution |
| GA204507A | Angle 0 ° | In distribution |
| GZA07C130 | Length 130 mm | In distribution |
| GA205010D | Length 50 mm | In distribution |
| GZB09AD28 | Length 28 mm | In distribution |
| GZB24AB08 | Width 8 mm | In distribution |
| GA206007C | Length 60 mm | In distribution |
| GCDABZZ18 | Length 18 mm | In distribution |
| GA205520D | Length 55 mm | In distribution |
| GA206014C | Length 60 mm | In distribution |
| GZB09AD20 | Length 20 mm | In distribution |
| GA245018D | Length 50 mm | In distribution |
| GB186520B | Length 65 mm | In distribution |
| GA206016C | Length 60 mm | In distribution |
| GZB16AF20 | Length 20 mm | In distribution |
| GA206016B | Length 60 mm | In distribution |
| GZB14AC02 | 2 | In distribution |
| GZB09SZ30 | Length 30 mm | In distribution |
| GDDBA5540 | Length 40 mm | In distribution |
| GA206010B | Length 60 mm | In distribution |
| GDDBA5530 | Length 30 mm | In distribution |
| GB186512D | Length 65 mm | In distribution |
| GB204016B | Length 40 mm | In distribution |
| GB186016D | Length 60 mm | In distribution |
| GZB11AC06 | 6 | In distribution |
| GZB13SQ03 | 3 | In distribution |
| GZB13SG03 | 3 | In distribution |
| GB186518A | Length 65 mm | In distribution |
| GB186518B | Length 65 mm | In distribution |
| GZB15AC05 | 5 | In distribution |
| GB204508A | Length 45 mm | In distribution |
| GDDAB6060 | Length 60 mm | In distribution |
| GZB13AC03 | 3 | In distribution |
| GZB16AE18 | Length 18 mm | In distribution |
| GZB13AC01 | 1 | In distribution |
| GZA07D080 | Length 80 mm | In distribution |
| GA204018D | Angle 15 ° | In distribution |
| GA246008C | Length 60 mm | In distribution |
| GB185518A | Length 55 mm | In distribution |
| GB204018C | Length 40 mm | In distribution |
| GZA07B120 | Length 120 mm | In distribution |
| GZA07A090 | Length 90 mm | In distribution |
| GZA07E110 | Length 110 mm | In distribution |
| GZA11R190 | Length 190 mm | In distribution |
| GCDCBZZ07 | Length 7 mm | In distribution |
| GZB18AB10 | Length 10 mm | In distribution |
| GZB17AC14 | Length 14 mm | In distribution |
| GZB16AB24 | Length 24 mm | In distribution |
| GZA11R130 | Length 130 mm | In distribution |
| GA245520C | Length 55 mm | In distribution |
| GB204510C | Length 45 mm | In distribution |
| GZA11L150 | Length 150 mm | In distribution |
| GB186012D | Length 60 mm | In distribution |
| GA244018B | Length 40 mm | In distribution |
| GA244018A | Length 40 mm | In distribution |
| GZB13AE01 | 1 | In distribution |
| GZB09SZ16 | Length 16 mm | In distribution |
| GA205514D | Length 55 mm | In distribution |
| GZA08A200 | Length 200 mm | In distribution |
| GZEA50DFC | Width 16 mm | In distribution |
| GDDBB6040 | Length 40 mm | In distribution |
| GA204510B | Angle 7 ° | In distribution |
| GA205008B | Length 50 mm | In distribution |
| GDDBB6060 | Length 60 mm | In distribution |
| GA204007A | Length 40 mm | In distribution |
| GZB16AB10 | Length 10 mm | In distribution |
| GCDCAZZ14 | Length 14 mm | In distribution |
| GB204016C | Length 40 mm | In distribution |
| GZB13SP06 | 6 | In distribution |
| GZB15SZ05 | 5 | In distribution |
| GZEA50BBB | Width 16 mm | In distribution |
| GCDBAZZ16 | Length 16 mm | In distribution |
| GA206016A | Length 60 mm | In distribution |
| GZB13SS01 | 1 | In distribution |
| GZB09AE28 | Length 28 mm | In distribution |
| GA205012B | Length 50 mm | In distribution |
| GB185512A | Length 55 mm | In distribution |
| GZB13S001 | 1 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
| CastleLoc-P Anterior Cervical Plate System | L&K Biomed Co., Ltd. | 873 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160702 | 2016-08-23 |
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.