Anthem
ANTHEM Wide Anterolateral Distal Tibia Plate, 2.5mm/3.5mm Polyaxial, Right, 10 hole, 175mm, SS
31manufacturers in China registered for this device type
1,538catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K163361 |
| Record published | 2019-09-20 |
| Record revised | 2024-02-19 (version 3) |
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, manufacturing date |
| Sizes | Length 8 to 325 mm; outer diameter 1.8 to 9 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7179.3054 | Length 54 mm | In distribution |
| 7179.5080 | Length 80 mm | In distribution |
| 1181.9130 | In distribution | |
| 1195.2213 | In distribution | |
| 7168.4034 | In distribution | |
| 7181.9198 | In distribution | |
| 1195.4214 | In distribution | |
| 7206.5050 | In distribution | |
| 7206.1075 | In distribution | |
| 7171.7520 | Outer Diameter 2.5 mm | In distribution |
| 2187.4718 | Length 294 mm | In distribution |
| 7171.6544 | In distribution | |
| 7181.5124 | In distribution | |
| 2195.2011 | In distribution | |
| 2206.3040 | In distribution | |
| 2179.4022 | Length 22 mm | In distribution |
| 2179.3056 | Length 56 mm | In distribution |
| 1185.1115 | Length 228 mm | In distribution |
| 1181.5215 | In distribution | |
| 1187.1104 | Length 102 mm | In distribution |
| 2181.5310 | In distribution | |
| 2181.6314 | In distribution | |
| 1170.1203 | In distribution | |
| 7168.7042 | In distribution | |
| 2195.2003 | In distribution | |
| 1181.9345 | In distribution | |
| 7168.4030 | Length 30 mm | In distribution |
| 2181.3412 | In distribution | |
| 7206.5060 | In distribution | |
| 1181.9235 | In distribution | |
| 1171.6536 | Length 36 mm | In distribution |
| 1186.4408 | 14mm Hook Depth | In distribution |
| 1170.1708 | In distribution | |
| 2187.4102 | Right | In distribution |
| 7181.5138 | In distribution | |
| 1181.3312 | In distribution | |
| 2181.2108 | In distribution | |
| 1179.3060 | Length 60 mm | In distribution |
| 1171.2188 | Dorsal Plate | In distribution |
| 7168.6042 | In distribution | |
| 2181.5255 | In distribution | |
| 7179.4050 | Outer Diameter 4 mm | In distribution |
| 7168.3045 | In distribution | |
| 2181.9234 | In distribution | |
| 2179.3036 | Outer Diameter 3.5 mm | In distribution |
| 2186.2624 | Deep Right Contour | In distribution |
| 2181.5234 | In distribution | |
| 7181.9180 | In distribution | |
| 7179.3020 | Outer Diameter 3.5 mm | In distribution |
| 2195.2007 | In distribution | |
| 2179.3505 | Length 64 mm | In distribution |
| 2179.2538 | Outer Diameter 2.5 mm | In distribution |
| 7171.6519 | Length 19 mm | In distribution |
| 1181.8213 | In distribution | |
| 1185.0404 | In distribution | |
| 2179.3045 | Length 45 mm | In distribution |
| 7181.9341 | In distribution | |
| 1179.0313 | 3 Hole Shaft | In distribution |
| 2186.2409 | Centered at 42% | In distribution |
| 1181.8217 | In distribution | |
| 2179.3546 | 16 Hole | In distribution |
| 6195.4110 | In distribution | |
| 2189.2823S | Right | In distribution |
| 2179.2544 | Outer Diameter 2.5 mm | In distribution |
| 2171.5530 | Length 30 mm | In distribution |
| 2171.6544 | Outer Diameter 2.5 mm | In distribution |
| 2181.9156 | In distribution | |
| 7181.9138 | In distribution | |
| 1186.3804 | 18mm Hook Depth | In distribution |
| 2168.2225 | Length 225 mm | In distribution |
| 2206.2050 | In distribution | |
| 1179.0016 | Length 190 mm | In distribution |
| 1170.2204 | In distribution | |
| 1171.1013 | 3 Hole | In distribution |
| 1181.9108 | In distribution | |
| 2179.1322 | Length 24 mm | In distribution |
| 1181.5238 | In distribution | |
| 1181.9193 | In distribution | |
| 2179.5054 | Length 54 mm | In distribution |
| 2195.2019 | In distribution | |
| 1186.0176 | Deep Contour | In distribution |
| 7181.9125 | In distribution | |
| 2195.3035 | In distribution | |
| 1168.6038 | Length 38 mm | In distribution |
| 1179.3509 | Length 111 mm | In distribution |
| 7179.4100 | Outer Diameter 4 mm | In distribution |
| 7168.4045 | Length 45 mm | In distribution |
| 2179.8032 | Outer Diameter 4 mm | In distribution |
| 2187.2114 | Length 232 mm | In distribution |
| 2206.2068 | In distribution | |
| 7179.4045 | Outer Diameter 4 mm | In distribution |
| 7181.4113 | In distribution | |
| 7206.7008 | In distribution | |
| 1179.3036 | Outer Diameter 3.5 mm | In distribution |
| 2189.1109S | Left | In distribution |
| 1181.9340 | In distribution | |
| 2181.9122 | In distribution | |
| 1181.1406 | In distribution | |
| 7181.9328 | In distribution | |
| 2181.9299 | In distribution | |
| 1206.8050 | In distribution | |
| 1179.4014 | Length 14 mm | In distribution |
| 2187.4308 | 8 Hole | In distribution |
| 2170.2708 | In distribution | |
| 1181.9298 | In distribution | |
| 7181.9155 | In distribution | |
| 7181.9343 | In distribution | |
| 1181.3208 | In distribution | |
| 1171.2303 | 3 Hole | In distribution |
| 2181.9274 | In distribution | |
| 1170.9003 | In distribution | |
| 6187.3201 | In distribution | |
| 2206.2024 | In distribution | |
| 1181.4207 | In distribution | |
| 1179.5048 | Length 48 mm | In distribution |
| 1195.4205 | In distribution | |
| 7206.1062 | In distribution | |
| 2171.6534 | Outer Diameter 2.5 mm | In distribution |
| 1186.2409 | Length 95 mm | In distribution |
| 2186.2604 | Shallow Right Contour | In distribution |
| 1179.4018 | Length 18 mm | In distribution |
| 1181.5246 | In distribution | |
| 2171.2155 | Dorsal Plate | In distribution |
| 1181.5216 | In distribution | |
| 1187.2106 | Right | In distribution |
| 2206.3095 | In distribution | |
| 7181.9330 | In distribution | |
| 2206.2036 | In distribution | |
| 2206.8035 | In distribution | |
| 2181.2406 | In distribution | |
| 1195.2223 | In distribution | |
| 1181.5210 | In distribution | |
| 7171.5016 | Length 16 mm | In distribution |
| 7181.9309 | In distribution | |
| 1181.9278 | In distribution | |
| 1168.6034 | Length 34 mm | In distribution |
| 1181.9189 | In distribution | |
| 6195.1210 | In distribution | |
| 1179.1322 | 2 Hole | In distribution |
| 2189.2900S | Right | In distribution |
| 2181.1512 | In distribution | |
| 1181.9127 | In distribution | |
| 1179.3052 | Length 52 mm | In distribution |
| 1181.9177 | In distribution | |
| 7181.4116 | In distribution | |
| 2179.2514 | Length 14 mm | In distribution |
| 2185.0407 | Length 126 mm | In distribution |
| 2186.3828 | Length 102 mm | In distribution |
| 1181.9167 | In distribution | |
| 1179.0039 | Length 116 mm | In distribution |
| 1181.9362 | In distribution | |
| 1181.9294 | In distribution | |
| 2181.9148 | In distribution | |
| 1168.3055 | Length 55 mm | In distribution |
| 2170.2132 | In distribution | |
| 7171.6580 | Length 80 mm | In distribution |
| 2170.1008 | In distribution | |
| 2181.4213 | In distribution | |
| 2181.9289 | In distribution | |
| 1171.1024 | Wide | In distribution |
| 2179.5008 | Length 8 mm | In distribution |
| 1171.6542 | Length 42 mm | In distribution |
| 2168.6042S | Length 42 mm | In distribution |
| 1179.2508 | Length 8 mm | In distribution |
| 1195.6202 | In distribution | |
| 2181.9328 | In distribution | |
| 2206.4085 | In distribution | |
| 1181.9338 | In distribution | |
| 1187.3720 | Length 320 mm | In distribution |
| 1186.3406 | Length 86 mm | In distribution |
| 1181.9342 | In distribution | |
| 1179.3537 | 7 Hole | In distribution |
| 2181.9391 | In distribution | |
| 2181.9332 | In distribution | |
| 7181.9266 | In distribution | |
| 2186.3808 | 18mm Hook Depth | In distribution |
| 2168.6030 | Length 30 mm | In distribution |
| 1185.2213 | 13 Hole | In distribution |
| 7171.5023 | Outer Diameter 2 mm | In distribution |
| 2181.9353 | In distribution | |
| 1195.6204 | In distribution | |
| 1206.8055 | In distribution | |
| 2181.9231 | In distribution | |
| 1171.5524 | Length 24 mm | In distribution |
| 1179.2536 | Outer Diameter 2.5 mm | In distribution |
| 7171.7528 | Outer Diameter 2.5 mm | In distribution |
| 2168.2285 | Length 285 mm | In distribution |
| 2170.1012 | In distribution | |
| 2168.6048S | Length 48 mm | In distribution |
| 2181.9320 | In distribution | |
| 1168.3060 | Length 60 mm | In distribution |
| 2181.9297 | In distribution | |
| 1187.2110 | Length 180 mm | In distribution |
| 2181.5312 | In distribution | |
| 1195.3214 | In distribution | |
| 2187.2108 | Length 154 mm | In distribution |
| 7181.9241 | In distribution | |
| 2179.0416 | 6 Hole Shaft | In distribution |
| 2189.1102S | Length 82.0 mm | In distribution |
| 7168.4044 | In distribution | |
| 1181.9257 | In distribution | |
| 2171.2305 | Narrow | In distribution |
| 7171.5516 | Outer Diameter 2.5 mm | In distribution |
| 1187.4504 | Length 95 mm | In distribution |
| 2181.9287 | In distribution | |
| 1181.5220 | In distribution | |
| 1185.0405 | 5 Hole | In distribution |
| 1181.9183 | In distribution | |
| 1170.0204 | In distribution | |
| 2171.1014 | Standard | In distribution |
| 2179.8065 | Length 65 mm | In distribution |
| 1179.3070 | Outer Diameter 3.5 mm | In distribution |
| 2181.9135 | In distribution | |
| 1179.0014 | 14 Hole | In distribution |
| 7181.9172 | In distribution | |
| 1179.2528 | Outer Diameter 2.5 mm | In distribution |
| 7179.3070 | Outer Diameter 3.5 mm | In distribution |
| 7181.5114 | In distribution | |
| 1170.2203 | In distribution | |
| 7181.9381 | In distribution | |
| 2171.2324 | 4 Hole | In distribution |
| 1187.4716 | Length 268 mm | In distribution |
| 2206.4090 | In distribution | |
| 1181.1208 | In distribution | |
| 1171.2015 | Standard | In distribution |
| 7171.5540 | Length 40 mm | In distribution |
| 1181.2112 | In distribution | |
| 2181.4224 | In distribution | |
| 7168.7034 | In distribution | |
| 7168.5032 | In distribution | |
| 2189.1310S | Left | In distribution |
| 2186.2427 | Centered at 42% | In distribution |
| 1185.1105 | left | In distribution |
| 7171.6555 | Length 55 mm | In distribution |
| 2181.1308 | In distribution | |
| 2186.3606 | 16mm Hook Depth | In distribution |
| 7181.9121 | In distribution | |
| 2195.3026 | In distribution | |
| 2179.4045 | Outer Diameter 4 mm | In distribution |
| 2181.9372 | In distribution | |
| 2171.1015 | Standard | In distribution |
| 2181.9142 | In distribution | |
| 7181.9169 | In distribution | |
| 2206.4075 | In distribution | |
| 2181.9110 | In distribution | |
| 1171.0444 | In distribution | |
| 2179.5038 | Outer Diameter 3.5 mm | In distribution |
| 1179.2546 | Outer Diameter 2.5 mm | In distribution |
| 2186.4806 | 6 Shaft Holes | In distribution |
| 7171.7519 | Length 19 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Volt | Synthes Gmbh | 1,444 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222409 | 2022-09-08 |
| K162825 | 2017-05-01 |
| K112028 | 2011-12-09 |
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.