Anthem
ANTHEM Wide Anterolateral Distal Tibia Plate, 2.5mm/3.5mm Polyaxial, Left, 10 hole, 175mm, SS
22manufacturers in China registered for this device type
1,551catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K163361 |
| Record published | 2018-07-26 |
| 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 |
|---|---|---|
| 2179.2540 | Length 40 mm | In distribution |
| 1186.2407 | Length 75 mm | In distribution |
| 1181.5236 | In distribution | |
| 2181.9145 | In distribution | |
| 1181.9241 | In distribution | |
| 1181.9230 | In distribution | |
| 7179.4042 | In distribution | |
| 1181.8207 | In distribution | |
| 2179.3512 | 12 Hole | In distribution |
| 2187.3116 | Left | In distribution |
| 2181.9120 | In distribution | |
| 7168.4058 | In distribution | |
| 1179.0003 | Outer Diameter 7 mm | In distribution |
| 7181.9134 | In distribution | |
| 2179.0315 | Length 67 mm | In distribution |
| 7171.5020 | Outer Diameter 2 mm | In distribution |
| 1195.3208 | In distribution | |
| 2189.1007S | Left | In distribution |
| 2181.9358 | In distribution | |
| 2181.9215 | In distribution | |
| 1195.3229 | In distribution | |
| 2181.9194 | In distribution | |
| 2170.2126 | In distribution | |
| 1179.5022 | Outer Diameter 3.5 mm | In distribution |
| 7181.9143 | In distribution | |
| 1181.9216 | In distribution | |
| 1181.8214 | In distribution | |
| 2181.5314 | In distribution | |
| 2181.4214 | In distribution | |
| 2179.3030 | Length 30 mm | In distribution |
| 7181.9390 | In distribution | |
| 2187.3714 | Length 242 mm | In distribution |
| 1181.8215 | In distribution | |
| 1181.9321 | In distribution | |
| 1181.9389 | In distribution | |
| 1179.3056 | Length 56 mm | In distribution |
| 1181.9346 | In distribution | |
| 7179.8090 | Length 90 mm | In distribution |
| 2185.2105 | 5 Hole | In distribution |
| 2181.9390 | In distribution | |
| 2206.3085 | In distribution | |
| 2170.1126 | In distribution | |
| 2181.9284 | In distribution | |
| 1187.3716 | 16 Hole | In distribution |
| 7181.9218 | In distribution | |
| 1186.2432 | Length 121 mm | In distribution |
| 2181.9319 | In distribution | |
| 1206.2070 | In distribution | |
| 2171.2314 | 4 Hole | In distribution |
| 7206.1085 | In distribution | |
| 1181.9300 | In distribution | |
| 2171.5516 | Length 16 mm | In distribution |
| 1181.9279 | In distribution | |
| 1181.9373 | In distribution | |
| 1206.2040 | In distribution | |
| 7181.9299 | In distribution | |
| 7181.9314 | In distribution | |
| 7171.5518 | Outer Diameter 2.5 mm | In distribution |
| 7181.9124 | In distribution | |
| 7168.4020 | Length 20 mm | In distribution |
| 2185.0412 | 12 Hole | In distribution |
| 2206.2062 | In distribution | |
| 2206.2040 | In distribution | |
| 7181.9118 | In distribution | |
| 2181.9200 | In distribution | |
| 7181.9142 | In distribution | |
| 1179.5010 | Length 10 mm | In distribution |
| 1179.0305 | 3 Hole Head | In distribution |
| 2179.2560 | Outer Diameter 2.5 mm | In distribution |
| 1179.5030 | Length 30 mm | In distribution |
| 1181.9256 | In distribution | |
| 7181.5144 | In distribution | |
| 2179.1304 | 4 Hole | In distribution |
| 1186.4628 | 16mm Hook Depth | In distribution |
| 2179.0014 | 14 Hole | In distribution |
| 2181.9357 | In distribution | |
| 7181.9245 | In distribution | |
| 1181.9328 | In distribution | |
| 1206.8060 | In distribution | |
| 2189.1823S | Length 306.0 mm | In distribution |
| 1181.9343 | In distribution | |
| 1186.0233 | Length 119 mm | In distribution |
| 1179.0008 | Length 94 mm | In distribution |
| 2171.0444 | In distribution | |
| 7179.4110 | Length 110 mm | In distribution |
| 7181.9269 | In distribution | |
| 7179.4020 | Length 20 mm | In distribution |
| 1170.1130 | In distribution | |
| 2181.3120 | In distribution | |
| 2179.1329 | Length 108 mm | In distribution |
| 1170.1112 | In distribution | |
| 1179.3065 | Length 65 mm | In distribution |
| 7181.4108 | In distribution | |
| 2181.9172 | In distribution | |
| 2171.6560 | Length 60 mm | In distribution |
| 1206.2028 | In distribution | |
| 1171.1015 | Standard | In distribution |
| 7171.4817 | Length 17 mm | In distribution |
| 7168.6032 | In distribution | |
| 2171.2303 | Narrow | In distribution |
| 1187.4508 | 8 Hole | In distribution |
| 7181.9190 | In distribution | |
| 2179.0036 | Length 77 mm | In distribution |
| 2181.5240 | In distribution | |
| 2181.9311 | In distribution | |
| 7181.9194 | In distribution | |
| 7181.9288 | In distribution | |
| 7181.5132 | In distribution | |
| 1171.6554 | Outer Diameter 2.5 mm | In distribution |
| 7206.1042 | In distribution | |
| 1181.9217 | In distribution | |
| 2181.2208 | In distribution | |
| 2181.9362 | In distribution | |
| 7181.9179 | In distribution | |
| 2181.3506 | In distribution | |
| 2181.3108 | In distribution | |
| 1179.0006 | Length 70 mm | In distribution |
| 1186.2429 | Deep Right Contour | In distribution |
| 1179.3050 | Length 50 mm | In distribution |
| 2189.1101S | Left | In distribution |
| 1179.8050 | Outer Diameter 4 mm | In distribution |
| 1181.3206 | In distribution | |
| 2171.2025 | Wide | In distribution |
| 2181.9107 | In distribution | |
| 2179.3014 | Outer Diameter 3.5 mm | In distribution |
| 1181.9377 | In distribution | |
| 1171.6530 | Outer Diameter 2.5 mm | In distribution |
| 2171.2304 | 4 Hole | In distribution |
| 2187.1104 | Length 102 mm | In distribution |
| 1206.2090 | In distribution | |
| 2181.8204 | In distribution | |
| 2179.1327 | 7 Hole | In distribution |
| 2179.3080 | Length 80 mm | In distribution |
| 2181.1106 | In distribution | |
| 1181.9270 | In distribution | |
| 1171.6552 | Length 52 mm | In distribution |
| 7181.9163 | In distribution | |
| 1179.2570 | Outer Diameter 2.5 mm | In distribution |
| 1181.9208 | In distribution | |
| 1171.2305 | 5 Hole | In distribution |
| 2181.9230 | In distribution | |
| 7168.5036 | In distribution | |
| 1187.4312 | 12 Hole | In distribution |
| 1171.5510 | Length 10 mm | In distribution |
| 2170.1710 | In distribution | |
| 2179.4014 | Outer Diameter 4 mm | In distribution |
| 7179.5100 | Length 100 mm | In distribution |
| 7179.5040 | Outer Diameter 3.5 mm | In distribution |
| 1168.6050 | Length 50 mm | In distribution |
| 2179.3506 | 6 Hole | In distribution |
| 2187.4714 | Right | In distribution |
| 1206.4090 | In distribution | |
| 2185.2107 | 7 Hole | In distribution |
| 7181.9297 | In distribution | |
| 2181.9191 | In distribution | |
| 7181.9340 | In distribution | |
| 1171.6516 | Length 16 mm | In distribution |
| 2171.6510 | Outer Diameter 2.5 mm | In distribution |
| 1206.3090 | In distribution | |
| 7181.9362 | In distribution | |
| 2181.9398 | In distribution | |
| 2181.9211 | In distribution | |
| 7181.9366 | In distribution | |
| 1206.4075 | In distribution | |
| 7171.4810 | Outer Diameter 1.8 mm | In distribution |
| 1179.3020 | Length 20 mm | In distribution |
| 2181.9144 | In distribution | |
| 1168.1088 | Length 88 mm | In distribution |
| 2181.9348 | In distribution | |
| 2179.0009 | Length 106 mm | In distribution |
| 1206.6080 | In distribution | |
| 1181.9142 | In distribution | |
| 2181.9229 | In distribution | |
| 2195.6004 | In distribution | |
| 7171.5530 | Length 30 mm | In distribution |
| 1181.4310 | In distribution | |
| 2181.9257 | In distribution | |
| 2170.9363 | In distribution | |
| 7181.9238 | In distribution | |
| 1187.3504 | Left | In distribution |
| 2187.4504 | 4 Hole | In distribution |
| 2181.9207 | In distribution | |
| 7179.4085 | Length 85 mm | In distribution |
| 1186.1608 | 8 Shaft Holes | In distribution |
| 7181.9116 | In distribution | |
| 7206.5065 | In distribution | |
| 2181.9209 | In distribution | |
| 1206.2054 | In distribution | |
| 7181.9109 | In distribution | |
| 2179.3514 | Length 169 mm | In distribution |
| 1179.3032 | Length 32 mm | In distribution |
| 7168.5052 | In distribution | |
| 1179.0044 | 14 Hole | In distribution |
| 2168.1315 | Length 315 mm | In distribution |
| 1181.9145 | In distribution | |
| 1181.9333 | In distribution | |
| 7171.6540 | Outer Diameter 2.5 mm | In distribution |
| 7179.5038 | Outer Diameter 3.5 mm | In distribution |
| 7181.5117 | In distribution | |
| 1186.4806 | Shallow Right Contour | In distribution |
| 1206.8075 | In distribution | |
| 2179.1324 | Length 48 mm | In distribution |
| 1185.1111 | left | In distribution |
| 7171.6532 | In distribution | |
| 1171.2013 | Standard | In distribution |
| 1187.4320 | Right | In distribution |
| 1181.9135 | In distribution | |
| 1181.9228 | In distribution | |
| 2189.2615S | Right | In distribution |
| 2189.2103S | Right | In distribution |
| 1181.3006 | In distribution | |
| 2171.6524 | Outer Diameter 2.5 mm | In distribution |
| 7179.3038 | Length 38 mm | In distribution |
| 2181.9288 | In distribution | |
| 2171.6528 | Length 28 mm | In distribution |
| 2179.3507 | Length 85 mm | In distribution |
| 1195.2203 | In distribution | |
| 7171.4826 | Length 26 mm | In distribution |
| 1181.2120 | In distribution | |
| 2189.2713S | Right | In distribution |
| 2186.4828 | Deep Right Contour | In distribution |
| 1170.1010 | In distribution | |
| 2189.2101S | Length 70.0 mm | In distribution |
| 2181.4210 | In distribution | |
| 7168.4028 | In distribution | |
| 1179.3014 | Outer Diameter 3.5 mm | In distribution |
| 2195.3014 | In distribution | |
| 7179.8060 | Length 60 mm | In distribution |
| 7168.4048 | In distribution | |
| 7206.5095 | In distribution | |
| 1181.4212 | In distribution | |
| 1187.4120 | 20 Hole | In distribution |
| 7181.9136 | In distribution | |
| 1181.9136 | In distribution | |
| 2179.5034 | Length 34 mm | In distribution |
| 1170.2028 | In distribution | |
| 1185.2103 | Length 75 mm | In distribution |
| 1186.0213 | Length 122 mm | In distribution |
| 7181.9106 | In distribution | |
| 6187.2100 | In distribution | |
| 7168.5030 | Length 30 mm | In distribution |
| 7171.5528 | Length 28 mm | In distribution |
| 1181.4208 | In distribution | |
| 1206.6045 | In distribution | |
| 2179.1303 | Length 36 mm | In distribution |
| 2170.1024 | In distribution | |
| 2171.0555 | In distribution | |
| 2181.3116 | In distribution | |
| 7179.4012 | Length 12 mm | In distribution |
| 2206.8040 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
| LCP | Synthes Gmbh | 1,295 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252166 | 2026-02-26 |
| K251161 | 2025-08-18 |
| K213591 | 2022-01-26 |
| K212433 | 2021-10-01 |
| K202496 | 2020-10-29 |
| K180554 | 2018-10-22 |
| K173166 | 2017-11-13 |
| K163361 | 2017-04-07 |
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.