Calix Spinal Implant System
11/12mm Lordotic Double Sided Trial Assembly, 13 x 16
21manufacturers in China registered for this device type
151catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 21. All 21 manufacturers in China registered for Template
Record
| Listed by | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-11-13 |
| Record revised | 2021-06-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Height 5 to 20 mm; length 22 to 36 mm; width 10 to 24 mm; depth 11 to 15 mm; angle 8 to 12 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X034-2705 | Length 28 mm | In distribution |
| X034-0737 | Width 10 mm | In distribution |
| X003-4008 | Depth 13 mm | In distribution |
| X034-2710 | Height 16 mm | In distribution |
| X034-2861 | Height 7 mm | In distribution |
| X034-2786 | Length 22 mm | In distribution |
| X034-1318 | Height 14 mm | In distribution |
| X003-4007 | 11/12mm height x 14mm width | In distribution |
| X034-2700 | Length 28 mm | In distribution |
| C003-0039 | In distribution | |
| X034-0978 | Length 22 mm | In distribution |
| X034-1310 | Width 10 mm | In distribution |
| X034-2867 | Width 10 mm | In distribution |
| X034-1060 | Height 16 mm | In distribution |
| X034-1171 | Height 10 mm | In distribution |
| X003-4011 | Depth 13 mm | In distribution |
| X034-2781 | Length 22 mm | In distribution |
| X034-0342 | Width 10 mm | In distribution |
| X034-1314 | Length 32 mm | In distribution |
| X034-2702 | Length 28 mm | In distribution |
| X034-1050 | Width 10 mm | In distribution |
| X034-0976 | Height 12 mm | In distribution |
| X034-1188 | Width 24 mm | In distribution |
| X034-2870 | Width 10 mm | In distribution |
| C003-0037 | In distribution | |
| X003-4023 | Depth 15 mm | In distribution |
| X003-4020 | Depth 15 mm | In distribution |
| X003-4013 | 7/8mm height x 16mm width | In distribution |
| X034-0731 | Width 10 mm | In distribution |
| X034-0734 | Width 10 mm | In distribution |
| X034-2780 | Length 22 mm | In distribution |
| X034-0346 | Width 10 mm | In distribution |
| X034-0349 | Length 28 mm | In distribution |
| C034-0210 | Height 10 mm | In distribution |
| X034-2788 | Length 22 mm | In distribution |
| X034-0972 | Length 22 mm | In distribution |
| X034-2864 | Width 10 mm | In distribution |
| X034-1172 | Length 36 mm | In distribution |
| X003-0041 | Height 11 mm | In distribution |
| X034-0977 | Length 22 mm | In distribution |
| X003-4022 | 9/10mm height x 18mm width | In distribution |
| C034-0208 | Height 8 mm | In distribution |
| X003-0039 | Height 9 mm | In distribution |
| C034-0207 | Height 7 mm | In distribution |
| X034-0740 | Width 10 mm | In distribution |
| X034-1315 | Length 32 mm | In distribution |
| X034-1191 | Length 36 mm | In distribution |
| X034-1312 | Height 8 mm | In distribution |
| C003-0035 | In distribution | |
| X034-2709 | Width 10 mm | In distribution |
| X034-0970 | Height 6 mm | In distribution |
| X003-4010 | Depth 13 mm | In distribution |
| X034-0736 | Width 10 mm | In distribution |
| X034-2783 | Height 9 mm | In distribution |
| X034-1170 | Length 36 mm | In distribution |
| X034-0971 | Width 10 mm | In distribution |
| C003-0036 | In distribution | |
| X034-2790 | Length 22 mm | In distribution |
| X034-0974 | Length 22 mm | In distribution |
| C034-0212 | Height 12 mm | In distribution |
| X003-4012 | 5/6mm height x 16mm width | In distribution |
| X034-2862 | Width 10 mm | In distribution |
| X034-1319 | Width 10 mm | In distribution |
| X034-2865 | Length 26 mm | In distribution |
| X034-2706 | Length 28 mm | In distribution |
| X034-0344 | Width 10 mm | In distribution |
| X003-0036 | Height 6 mm | In distribution |
| X034-0738 | Height 14 mm | In distribution |
| X034-2787 | Width 10 mm | In distribution |
| X034-0348 | Width 10 mm | In distribution |
| X034-0732 | Width 10 mm | In distribution |
| C034-0215 | Height 15 mm | In distribution |
| X034-1186 | Angle 12 ° | In distribution |
| X034-2707 | Width 10 mm | In distribution |
| C034-0206 | Height 6 mm | In distribution |
| C003-0041 | In distribution | |
| X034-0979 | Height 15 mm | In distribution |
| X034-1052 | Height 8 mm | In distribution |
| C034-0214 | Height 14 mm | In distribution |
| X034-0730 | Width 10 mm | In distribution |
| X034-1174 | Angle 8 ° | In distribution |
| X034-1176 | Angle 8 ° | In distribution |
| X034-2860 | Height 6 mm | In distribution |
| X034-1058 | Height 14 mm | In distribution |
| X003-4018 | 9/10mm height x 18 mm width | In distribution |
| X034-1175 | Width 24 mm | In distribution |
| X003-0037 | Height 7 mm | In distribution |
| C003-0034 | In distribution | |
| X034-1317 | Length 32 mm | In distribution |
| C034-0211 | Height 11 mm | In distribution |
| C003-0038 | In distribution | |
| X034-2785 | Width 10 mm | In distribution |
| X034-2863 | Height 9 mm | In distribution |
| X034-1189 | Width 24 mm | In distribution |
| X034-1187 | Height 12 mm | In distribution |
| X034-1311 | Height 7 mm | In distribution |
| X034-1185 | Angle 12 ° | In distribution |
| X034-2869 | Length 26 mm | In distribution |
| X003-4009 | 7/8mm height x 16mm width | In distribution |
| X034-1059 | Height 15 mm | In distribution |
| X034-0341 | Length 28 mm | In distribution |
| X034-0350 | Height 16 mm | In distribution |
| X034-2789 | Height 15 mm | In distribution |
| X003-4005 | 7/8mm height x 14mm width | In distribution |
| X034-0975 | Length 22 mm | In distribution |
| X003-4001 | 7/8mm height x 14mm width | In distribution |
| X034-0735 | Height 11 mm | In distribution |
| X034-0739 | Width 10 mm | In distribution |
| X034-2701 | Length 28 mm | In distribution |
| C034-0216 | Height 16 mm | In distribution |
| X034-1051 | Height 7 mm | In distribution |
| X034-2782 | Height 8 mm | In distribution |
| X003-0038 | Height 8 mm | In distribution |
| X003-0042 | Height 12 mm | In distribution |
| C003-0040 | In distribution | |
| X034-0347 | Height 13 mm | In distribution |
| X034-1190 | Width 24 mm | In distribution |
| X003-0040 | Height 10 mm | In distribution |
| X034-2703 | Height 9 mm | In distribution |
| X034-2704 | Width 10 mm | In distribution |
| X034-0980 | Width 10 mm | In distribution |
| X003-0035 | Height 5 mm | In distribution |
| X034-2866 | Width 10 mm | In distribution |
| X034-1057 | Height 13 mm | In distribution |
| X034-0733 | Height 9 mm | In distribution |
| X034-2784 | Width 10 mm | In distribution |
| X003-4015 | 11/12mm height x 16mm width | In distribution |
| X034-0340 | Width 10 mm | In distribution |
| X034-1173 | Height 14 mm | In distribution |
| X003-4017 | Depth 15 mm | In distribution |
| X003-4002 | 9/10mm height x 14mm width | In distribution |
| X034-1056 | Height 12 mm | In distribution |
| X003-4000 | Depth 11 mm | In distribution |
| X034-0973 | Length 22 mm | In distribution |
| X003-4019 | 11/12mm height x 18mm width | In distribution |
| X003-4006 | 9/10mm height x 14mm width | In distribution |
| X003-4004 | 5/6mm height x 14mm width | In distribution |
| X003-4021 | Depth 15 mm | In distribution |
| X034-1054 | Length 26 mm | In distribution |
| X034-2708 | Length 28 mm | In distribution |
| X034-1055 | Width 10 mm | In distribution |
| X003-4014 | Depth 13 mm | In distribution |
| C034-0209 | Height 9 mm | In distribution |
| X034-2868 | Length 26 mm | In distribution |
| X003-4016 | Depth 15 mm | In distribution |
| X034-1313 | Width 10 mm | In distribution |
| X034-1053 | Height 9 mm | In distribution |
| C034-0213 | Height 13 mm | In distribution |
| X034-1320 | Width 10 mm | In distribution |
| X003-4003 | 11/12mm height x 14mm width | In distribution |
| X034-1316 | Length 32 mm | In distribution |
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|---|---|---|
| Attune | Depuy (Ireland) | 1,385 |
| Template | Exactech, Inc. | 1,277 |
| 4WEB Medical | 4WEB Inc. | 991 |
| Evolution® | Microport Orthopedics Inc. | 966 |
| Template | Zimmer, Inc. | 792 |
| Advance® | Microport Orthopedics Inc. | 644 |
| Apex Knee System | Omni Life Science, Inc. | 635 |
| Profemur® | Microport Orthopedics Inc. | 591 |
| Link Instruments – Trial implants and size gauges | Waldemar Link GmbH & Co. KG | 549 |
| Template | Synthes Gmbh | 516 |
| Optetrak Logic | Exactech, Inc. | 512 |
| Template | Depuy Spine, Inc. | 451 |
Showing 12 of 2,940. All products under Template
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.