Bioplate®
Straight Plate - Low-Profile - 2 hole - 11 mm (3), Self-Drilling Screw - 4 mm (6) [5 PK]
22manufacturers in China registered for this device type
43catalogue 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 | Bioplate, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K082757 |
| Record published | 2015-10-22 |
| Record revised | 2025-06-09 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| Sizes | Length 10 to 24 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 81-5721 | Length 11 mm | In distribution | |
| 81-5721[US] | Length 11 mm | In distribution | |
| 81-5888 | In distribution | ||
| 81-5887 | In distribution | ||
| 81-3590 | In distribution | ||
| 81-5722 | Length 11 mm | 5 | In distribution |
| 81-5724[US] | Length 19 mm | In distribution | |
| 81-5729[US] | Length 17 mm | In distribution | |
| 81-5726 | Length 17 mm | In distribution | |
| 81-5724-CP | Length 19 mm | 5 | In distribution |
| 81-5727-CP | Length 15 mm | 5 | In distribution |
| 81-5726[US] | Length 17 mm | In distribution | |
| 81-5734 | Length 12 mm | In distribution | |
| 81-5730 | Length 24 mm | In distribution | |
| 81-5728 | Length 10 mm | In distribution | |
| 81-3591 | In distribution | ||
| 81-5733[US] | Length 18 mm | In distribution | |
| 81-5728-CP | Length 10 mm | 5 | In distribution |
| 81-5726-CP | Length 17 mm | 5 | In distribution |
| 81-5728[US] | Length 10 mm | In distribution | |
| 81-5886 | In distribution | ||
| 81-5733 | Length 18 mm | In distribution | |
| 81-5724 | Length 19 mm | In distribution | |
| 81-5721-CP | Length 11 mm | 5 | In distribution |
| 81-5734[US] | Length 12 mm | In distribution | |
| 81-5722[US] | Length 11 mm | 5 | In distribution |
| 81-5725-CP | Length 18 mm | 5 | In distribution |
| 81-5727[US] | Length 15 mm | In distribution | |
| 81-5725[US] | Length 18 mm | In distribution | |
| 81-5725 | Length 18 mm | In distribution | |
| 81-5729-CP | Length 17 mm | 5 | In distribution |
| 81-5730[US] | Length 24 mm | In distribution | |
| 81-5892 | In distribution | ||
| 81-5885 | In distribution | ||
| 81-5734-CP | Length 12 mm | 5 | In distribution |
| 81-5893 | In distribution | ||
| 81-5723 | Length 14 mm | In distribution | |
| 81-5729 | Length 17 mm | In distribution | |
| 81-5727 | Length 15 mm | In distribution | |
| 81-5730-CP | Length 24 mm | 5 | In distribution |
| 81-3592 | In distribution | ||
| 81-5723[US] | Length 14 mm | In distribution | |
| 81-5723-CP | Length 14 mm | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bioplate, Inc. | 510(k) number | 2010-03-31 | Not classified | Process design | There is potential defect in seal of the sterile barrier containing the device. | 16,020 Individual Kits; 2,226 Boxes. | 2012-04-04 |
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.