TiMesh
Plate 015-230 Single Y 3HX3H 2.5MM 1.07W
22manufacturers in China registered for this device type
113catalogue numbers in this listing
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 | Medtronic PS Medical, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K062348 |
| Record published | 2016-06-18 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 3.3 to 200 mm; width 1.5 to 200 mm; height 0.3 to 0.6 mm; outer diameter 1.5 to 18 mm; lumen/inner diameter 3 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000-2090 | In distribution | |
| 8001531-6 | Width 148.0 mm | In distribution |
| 015-2001-4-C | Width 75.0 mm | In distribution |
| 016-200 | Width 200.0 mm | In distribution |
| 015-230 | Width 2.5 mm | In distribution |
| 015-016 | Length 3.3 mm | In distribution |
| 015-044-C | In distribution | |
| 000-2090 | In distribution | |
| 015-040 | Length 4.0 mm | In distribution |
| 016-152 | In distribution | |
| 015-237 | In distribution | |
| 015-016-C | Length 3.3 mm | In distribution |
| 015-247 | Width 5.0 mm | In distribution |
| 015-042 | Length 8.0 mm | In distribution |
| 015-2010 | In distribution | |
| 015-018 | Length 5.0 mm | In distribution |
| 8001511-3 | In distribution | |
| 015-2050 | In distribution | |
| 015-130 | In distribution | |
| 015-2001-5 | Width 5.0 mm | In distribution |
| 090 | Length 150.0 mm | In distribution |
| 8002233-6 | Height 0.6 mm | In distribution |
| 015-102R | In distribution | |
| 015-042-C | Length 8.0 mm | In distribution |
| 015-017 | In distribution | |
| 015-016-C | In distribution | |
| 015-040 | In distribution | |
| 015-018-C | In distribution | |
| 8001603 | In distribution | |
| 8004200 | In distribution | |
| 015-257 | In distribution | |
| 015-260-14 | In distribution | |
| 015-246 | In distribution | |
| 015-247 | In distribution | |
| 015-260-11 | In distribution | |
| 015-255 | In distribution | |
| 090 | In distribution | |
| 016-120 | In distribution | |
| 015-233 | Width 2.5 mm | In distribution |
| 016-200 | In distribution | |
| 015-2001-5-C | Width 75.0 mm | In distribution |
| 015-2001-4 | In distribution | |
| 015-246 | Width 2.5 mm | In distribution |
| 016-100 | In distribution | |
| 015-044 | In distribution | |
| 015-257 | In distribution | |
| 8004101 | In distribution | |
| 8001603 | In distribution | |
| 015-257-C | Width 10.7 mm | In distribution |
| 015-276 | In distribution | |
| 015-160 | In distribution | |
| 015-2050 | Width 75.0 mm | In distribution |
| 016-128 | In distribution | |
| 015-275 | In distribution | |
| 8001225 | Outer Diameter 1.5 mm | In distribution |
| 015-017 | Length 4.0 mm | In distribution |
| 015-2010 | Width 45.0 mm | In distribution |
| 015-233 | In distribution | |
| 015-257-C | In distribution | |
| 015-255 | In distribution | |
| 015-040-C | In distribution | |
| 015-090 | In distribution | |
| 016-152 | Length 152.0 mm | In distribution |
| 8001511-6 | In distribution | |
| 235 | Width 79.0 mm | In distribution |
| 015-160 | In distribution | |
| 015-260-14 | Outer Diameter 14.0 mm | In distribution |
| 015-2001-5-C | In distribution | |
| 015-258 | In distribution | |
| 241-02 | In distribution | |
| 8002233-6 | In distribution | |
| 016-128 | Length 128.0 mm | In distribution |
| 8001521-3 | Length 113.0 mm | In distribution |
| 015-016 | In distribution | |
| 8001531-6 | In distribution | |
| 016-120 | Width 120.0 mm | In distribution |
| 015-018 | In distribution | |
| 015-236 | In distribution | |
| 015-276 | Outer Diameter 10.0 mm | In distribution |
| 015-102R | Length 28.5 mm | In distribution |
| 015-260-11 | Outer Diameter 11.0 mm | In distribution |
| 8001523-6 | In distribution | |
| 8001521-6 | In distribution | |
| 015-2001-4-C | In distribution | |
| 015-2001-4 | Width 75.0 mm | In distribution |
| 015-273 | In distribution | |
| 015-044-C | Length 12.0 mm | In distribution |
| 8001225 | Width 1.5 mm | In distribution |
| 8001511-3 | Width 50.0 mm | In distribution |
| 8001533-6 | In distribution | |
| 015-018-C | Length 5.0 mm | In distribution |
| 015-273 | In distribution | |
| 241-02 | Length 121.0 mm | In distribution |
| 015-258 | In distribution | |
| 015-260-18 | Outer Diameter 18.0 mm | In distribution |
| 015-090 | In distribution | |
| 015-275 | Outer Diameter 8.4 mm | In distribution |
| 8001521-6 | Length 113.0 mm | In distribution |
| 015-042 | In distribution | |
| 015-236 | Width 2.5 mm | In distribution |
| 015-237 | Width 5.0 mm | In distribution |
| 016-100 | Length 100.0 mm | In distribution |
| 015-044 | Length 12.0 mm | In distribution |
| 235 | In distribution | |
| 015-040-C | Length 4.0 mm | In distribution |
| 8001511-6 | Height 0.6 mm | In distribution |
| 8001533-6 | Length 148.0 mm | In distribution |
| 015-260-18 | In distribution | |
| 015-230 | In distribution | |
| 8001521-3 | In distribution | |
| 8001523-6 | Width 77.0 mm | In distribution |
| 015-042-C | In distribution | |
| 015-2001-5 | In distribution |
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 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
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.