Creo
Open-Closed Lateral Connector, 6.5 Open to 5.5-6.35 Closed, 3 Set Screws, 12mm Wide, SS
14manufacturers in China registered for this device type
1,765catalogue numbers in this listing
15510(k) clearances naming this product code
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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K180210 |
| Record published | 2023-06-10 |
| Record revised | 2025-07-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 3.5 to 10.5 mm; length 15 to 700 mm; width 3.5 to 16.25 mm; height 9.15 to 31.8 mm; lumen/inner diameter 4 to 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5148.1760 | In distribution | |
| 5119.5780 | Outer Diameter 7.5 mm | In distribution |
| 7119.6026 | Length 25 mm | In distribution |
| 5067.6797 | Length 95 mm | In distribution |
| 5148.0427 | Outer Diameter 5 mm | In distribution |
| 5119.1137 | Length 35 mm | In distribution |
| 5146.7635 | Outer Diameter 6.5 mm | In distribution |
| 1067.1712 | Outer Diameter 7.5 mm | In distribution |
| 5119.9775 | Outer Diameter 7.5 mm | In distribution |
| 5119.1585 | Outer Diameter 5.5 mm | In distribution |
| 5119.5835 | Length 35 mm | In distribution |
| 5119.2630 | Length 30 mm | In distribution |
| 5067.5545 | Length 45 mm | In distribution |
| 5119.2942 | Outer Diameter 9.5 mm | In distribution |
| 7119.5150 | Outer Diameter 5.5 mm | In distribution |
| 5067.5522 | Outer Diameter 5.5 mm | In distribution |
| 1067.1230 | Outer Diameter 4 mm | In distribution |
| 1134.5210 | Outer Diameter 5.5 mm | In distribution |
| 5146.6535 | Outer Diameter 5.5 mm | In distribution |
| 1067.0830 | Length 25 mm | In distribution |
| 1119.0620 | Length 20 mm | In distribution |
| 5146.4572 | Outer Diameter 5.5 mm | In distribution |
| 1119.9890 | Width 6 mm | In distribution |
| 1134.6150 | Outer Diameter 6 mm | In distribution |
| 5119.5147 | Outer Diameter 10.5 mm | In distribution |
| 7134.6085 | Outer Diameter 6 mm | In distribution |
| 5148.0982 | Outer Diameter 9.5 mm | In distribution |
| 1119.0928 | Width 15 mm | In distribution |
| 5146.2145 | Length 45 mm | In distribution |
| 5119.2912 | Outer Diameter 9.5 mm | In distribution |
| 5067.0826S | Outer Diameter 8.5 mm | In distribution |
| 5067.9440 | Length 40 mm | In distribution |
| 7119.6600 | Length 600 mm | In distribution |
| 5067.7920 | Outer Diameter 9.5 mm | In distribution |
| 5148.3897 | Outer Diameter 8.5 mm | In distribution |
| 5119.5862 | Length 60 mm | In distribution |
| 5067.7692 | Length 90 mm | In distribution |
| 5067.4029 | Length 82.5 mm | In distribution |
| 5146.5045 | Outer Diameter 6 mm | In distribution |
| 5146.5810 | Outer Diameter 8.5 mm | In distribution |
| 1175.5530 | Outer Diameter 5.5 mm | In distribution |
| 5148.0150 | In distribution | |
| 5067.1365 | Outer Diameter 4.5 mm | In distribution |
| 5119.4011 | Length 110 mm | In distribution |
| 7067.5090 | Outer Diameter 4.75 mm | In distribution |
| 5192.1635 | Length 35 mm | In distribution |
| 5067.8350 | Length 50 mm | In distribution |
| 5146.2012 | Outer Diameter 6 mm | In distribution |
| 5119.1962 | Length 60 mm | In distribution |
| 5119.7325 | Outer Diameter 4.5 mm | In distribution |
| 7120.3026 | Length 25 mm | In distribution |
| 5146.5020 | Outer Diameter 6 mm | In distribution |
| 7134.5220 | Length 220 mm | In distribution |
| 5067.4016 | Length 97.5 mm | In distribution |
| 7119.6045 | Length 45 mm | In distribution |
| 5119.0677 | Length 75 mm | In distribution |
| 5067.2687 | Outer Diameter 6.5 mm | In distribution |
| 5067.0459S | Length 57.5 mm | In distribution |
| 5146.4992 | Length 90 mm | In distribution |
| 5119.1546S | Outer Diameter 5.5 mm | In distribution |
| 5119.2911 | Outer Diameter 9.5 mm | In distribution |
| 5192.1740 | Length 40 mm | In distribution |
| 5119.9760 | Outer Diameter 7.5 mm | In distribution |
| 5067.6265 | Length 65 mm | In distribution |
| 5119.2632 | Outer Diameter 5 mm | In distribution |
| 5067.0471S | Outer Diameter 5 mm | In distribution |
| 5146.2185 | Length 85 mm | In distribution |
| 5119.1611 | Outer Diameter 6.5 mm | In distribution |
| 5119.1847 | Length 45 mm | In distribution |
| 1067.9824 | Height 16 mm | In distribution |
| 5067.1562 | Outer Diameter 5.5 mm | In distribution |
| 5067.2057 | Length 55 mm | In distribution |
| 5148.0757 | Length 55 mm | In distribution |
| 1067.9740 | Width 3.5 mm | In distribution |
| 5119.4850 | Length 50 mm | In distribution |
| 5146.7575 | Outer Diameter 5.5 mm | In distribution |
| 5146.7235 | Outer Diameter 4 mm | In distribution |
| 5067.7525 | Length 25 mm | In distribution |
| 1192.1960 | In distribution | |
| 5119.2260 | Outer Diameter 6.5 mm | In distribution |
| 5119.4785 | Outer Diameter 7.5 mm | In distribution |
| 5119.2590 | Outer Diameter 4.5 mm | In distribution |
| 5067.7167 | Length 65 mm | In distribution |
| 5067.7965 | Length 65 mm | In distribution |
| 1120.3745 | Outer Diameter 6 mm | In distribution |
| 5067.1127 | Length 25 mm | In distribution |
| 5067.7597 | Outer Diameter 5.5 mm | In distribution |
| 5067.0486S | Length 85 mm | In distribution |
| 5067.6755 | Outer Diameter 7.5 mm | In distribution |
| 5146.5995 | Outer Diameter 9.5 mm | In distribution |
| 1119.0325 | Length 25 mm | In distribution |
| 5119.0657 | Length 55 mm | In distribution |
| 5148.3270 | Length 70 mm | In distribution |
| 1119.9846 | Height 24.1 mm | In distribution |
| 5067.1742 | Outer Diameter 7.5 mm | In distribution |
| 5119.1985 | Length 85 mm | In distribution |
| 5146.4662 | Length 60 mm | In distribution |
| 1134.6130 | Outer Diameter 6 mm | In distribution |
| 5119.7685 | Outer Diameter 6.5 mm | In distribution |
| 1175.2471 | Width 10 mm | In distribution |
| 1192.1765 | Length 65 mm | In distribution |
| 5119.5511 | Outer Diameter 5.5 mm | In distribution |
| 5067.1825 | Length 25 mm | In distribution |
| 5067.6590 | Length 90 mm | In distribution |
| 5148.1970 | Length 70 mm | In distribution |
| 1067.2790 | Length 90 mm | In distribution |
| 5146.7640 | Length 40 mm | In distribution |
| 5148.1730 | In distribution | |
| 7119.5091 | Outer Diameter 5.5 mm | In distribution |
| 5067.0379S | Length 77.5 mm | In distribution |
| 5146.2518 | Outer Diameter 4.5 mm | In distribution |
| 5148.0665 | In distribution | |
| 5146.2022 | Outer Diameter 6 mm | In distribution |
| 5148.3197 | Outer Diameter 9 mm | In distribution |
| 1067.4560 | Outer Diameter 5.5 mm | In distribution |
| 5146.4762 | Outer Diameter 7.5 mm | In distribution |
| 5119.1170 | Outer Diameter 10.5 mm | In distribution |
| 1067.2580 | Outer Diameter 4.5 mm | In distribution |
| 1067.6600 | Length 600 mm | In distribution |
| 5067.2220 | Length 20 mm | In distribution |
| 5119.6390 | Length 90 mm | In distribution |
| 5192.1782 | Length 80 mm | In distribution |
| 5119.2240 | Outer Diameter 8 mm | In distribution |
| 5067.7972 | Length 70 mm | In distribution |
| 7119.7056 | Outer Diameter 5.5 mm | In distribution |
| 7120.3201 | Outer Diameter 6 mm | In distribution |
| 5119.7130 | Outer Diameter 10.5 mm | In distribution |
| 5067.1850 | Length 50 mm | In distribution |
| 5067.6167 | Outer Diameter 10.5 mm | In distribution |
| 5067.3427 | Outer Diameter 6 mm | In distribution |
| 5148.0744 | Length 120 mm | In distribution |
| 5119.6410 | Outer Diameter 5 mm | In distribution |
| 5119.8240 | Outer Diameter 4 mm | In distribution |
| 1067.4555 | Length 55 mm | In distribution |
| 5148.0182 | Outer Diameter 10.5 mm | In distribution |
| 5120.4817 | Outer Diameter 8.5 mm | In distribution |
| 5119.5530 | Length 30 mm | In distribution |
| 5119.6875 | Length 75 mm | In distribution |
| 5067.6420 | Length 20 mm | In distribution |
| 1067.0990 | Length 35 mm | In distribution |
| 5067.5717 | Length 110 mm | In distribution |
| 1067.7070 | Length 70 mm | In distribution |
| 5119.2565 | Outer Diameter 4.5 mm | In distribution |
| 5119.5812 | Outer Diameter 8.5 mm | In distribution |
| 5119.1580 | Length 80 mm | In distribution |
| 1119.8762 | Outer Diameter 5.5 mm | In distribution |
| 5148.0562 | Length 60 mm | In distribution |
| 5067.5275 | Length 75 mm | In distribution |
| 5119.2048S | Outer Diameter 6 mm | In distribution |
| 5067.9950 | Length 50 mm | In distribution |
| 5119.7711 | Outer Diameter 7.5 mm | In distribution |
| 7134.5065 | Outer Diameter 5.5 mm | In distribution |
| 1120.2030 | Length 30 mm | In distribution |
| 7119.7051 | Length 50 mm | In distribution |
| 1067.7785 | Outer Diameter 4.75 mm | In distribution |
| 1119.0940 | Width 15 mm | In distribution |
| 1119.7095 | Length 95 mm | In distribution |
| 5067.0522 | Outer Diameter 5.5 mm | In distribution |
| 5067.0591S | Length 90 mm | In distribution |
| 5119.0112 | Outer Diameter 10.5 mm | In distribution |
| 5119.6530 | Outer Diameter 5.5 mm | In distribution |
| 1192.1880 | Length 80 mm | In distribution |
| 5067.0957 | Outer Diameter 9.5 mm | In distribution |
| 5192.1780 | Length 80 mm | In distribution |
| 5067.0195 | Outer Diameter 10.5 mm | In distribution |
| 5119.5111 | Outer Diameter 10.5 mm | In distribution |
| 5119.8675 | Length 75 mm | In distribution |
| 5119.9375 | Length 75 mm | In distribution |
| 5146.6370 | Length 70 mm | In distribution |
| 5067.7117 | Outer Diameter 10.5 mm | In distribution |
| 5119.6560 | Length 60 mm | In distribution |
| 5119.2877 | Outer Diameter 7 mm | In distribution |
| 5192.1640 | Length 40 mm | In distribution |
| 5192.1842 | Length 40 mm | In distribution |
| 5119.8770 | Length 70 mm | In distribution |
| 5119.1537 | Outer Diameter 5.5 mm | In distribution |
| 5148.0050 | Outer Diameter 6 mm | In distribution |
| 5119.8670 | Outer Diameter 6.5 mm | In distribution |
| 5119.5118 | Outer Diameter 10.5 mm | In distribution |
| 5119.5311 | Outer Diameter 4.5 mm | In distribution |
| 5146.7330 | Outer Diameter 4.5 mm | In distribution |
| 5119.2927 | Outer Diameter 8 mm | In distribution |
| 5067.0696S | Length 95 mm | In distribution |
| 5119.9490 | Outer Diameter 5 mm | In distribution |
| 5067.0894S | Length 92.5 mm | In distribution |
| 5119.2587 | Outer Diameter 4.5 mm | In distribution |
| 5067.5375 | Length 75 mm | In distribution |
| 5119.1145 | Length 45 mm | In distribution |
| 5119.2572 | Outer Diameter 5.5 mm | In distribution |
| 7120.2060 | Outer Diameter 6 mm | In distribution |
| 5067.0815S | Length 120 mm | In distribution |
| 5119.5150 | Length 50 mm | In distribution |
| 5146.5411 | Length 110 mm | In distribution |
| 5067.0842 | Length 40 mm | In distribution |
| 5067.1520 | Length 20 mm | In distribution |
| 5067.2017 | Length 110 mm | In distribution |
| 5119.5327 | Outer Diameter 4.5 mm | In distribution |
| 5067.9380 | Length 80 mm | In distribution |
| 5067.7717 | Length 110 mm | In distribution |
| 5067.1432 | Outer Diameter 5 mm | In distribution |
| 5067.1282 | Outer Diameter 4 mm | In distribution |
| 5067.2560 | Outer Diameter 5.5 mm | In distribution |
| 5119.6625 | Length 25 mm | In distribution |
| 5146.1890 | Outer Diameter 8.5 mm | In distribution |
| 5146.7150 | Outer Diameter 10.5 mm | In distribution |
| 7119.6035 | Outer Diameter 5.5 mm | In distribution |
| 7120.2400 | Outer Diameter 6 mm | In distribution |
| 5146.5795 | Outer Diameter 7.5 mm | In distribution |
| 5067.2690 | Outer Diameter 5 mm | In distribution |
| 5146.5062 | Length 60 mm | In distribution |
| 5067.3089 | Length 72.5 mm | In distribution |
| 5067.1347 | Length 45 mm | In distribution |
| 5067.1840 | Length 40 mm | In distribution |
| 7067.8870 | Length 18 mm | In distribution |
| 5067.6792 | Outer Diameter 7.5 mm | In distribution |
| 1175.5422 | Width 12 mm | In distribution |
| 7134.6350 | Outer Diameter 6 mm | In distribution |
| 1067.1150 | Length 50 mm | In distribution |
| 5067.8597 | Outer Diameter 5.5 mm | In distribution |
| 5067.8520 | Outer Diameter 5.5 mm | In distribution |
| 5119.1743S | Outer Diameter 7.5 mm | In distribution |
| 5146.4032 | Length 30 mm | In distribution |
| 7119.5400 | Outer Diameter 5.5 mm | In distribution |
| 5119.0455 | Outer Diameter 5 mm | In distribution |
| 5146.5157 | Length 55 mm | In distribution |
| 5067.5290 | Length 90 mm | In distribution |
| 1119.0086 | Length 90 mm | In distribution |
| 5146.1312 | Length 120 mm | In distribution |
| 6148.3000 | In distribution | |
| 5067.5950 | Outer Diameter 9.5 mm | In distribution |
| 5148.2811 | Outer Diameter 7 mm | In distribution |
| 5119.2811 | Length 110 mm | In distribution |
| 1067.1775 | Length 75 mm | In distribution |
| 5148.5330 | Outer Diameter 4.5 mm | In distribution |
| 1119.7704 | Length 400 mm | In distribution |
| 5119.6712 | Outer Diameter 7.5 mm | In distribution |
| 7119.8730 | Length 300 mm | In distribution |
| 7119.7040 | Length 40 mm | In distribution |
| 5119.7460 | Outer Diameter 5 mm | In distribution |
| 5148.0555 | Outer Diameter 5.5 mm | In distribution |
| 1119.9957 | Height 22.15 mm | In distribution |
| 1119.0136 | Length 43 mm | In distribution |
| 5067.5510 | Outer Diameter 5.5 mm | In distribution |
| 5146.5711 | Length 110 mm | In distribution |
| 5192.1632 | Length 30 mm | In distribution |
| 5067.5892 | Outer Diameter 8.5 mm | In distribution |
| 5119.2218 | Length 120 mm | In distribution |
| 5119.5510 | Outer Diameter 5.5 mm | In distribution |
| 5119.1390 | Length 90 mm | In distribution |
| 5119.7265 | Length 65 mm | 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 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| 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 |
|---|---|
| K233735 | 2024-01-25 |
| K232318 | 2023-10-31 |
| K192314 | 2019-10-23 |
| K183056 | 2019-04-19 |
| K181846 | 2018-11-06 |
| K133567 | 2014-02-20 |
| K121049 | 2012-06-27 |
| K120092 | 2012-04-13 |
| K092146 | 2009-11-16 |
| K092108 | 2009-08-13 |
| K081391 | 2008-07-03 |
| K070775 | 2007-04-19 |
| K062836 | 2006-12-19 |
| K062407 | 2006-09-06 |
| K040721 | 2004-06-17 |
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.