View Plating System, Reduce Fracture Plating System
Lapidus Plate, Small, 2MM Step, Right
31manufacturers in China registered for this device type
73catalogue numbers in this listing
2510(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 | Orthofix SRL, Italy |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K140876 |
| Record published | 2017-06-07 |
| Record revised | 2025-11-20 (version 9) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 8 to 48 mm; outer diameter 2 to 3.2 mm |
| Distribution end date | 2019-10-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Length 20 mm | In distribution |
| 1 | Length 12 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Length 12 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Length 22 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | Length 38 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Length 10 mm | In distribution |
| 1 | Length 26 mm | In distribution |
| 1 | Length 18 mm | In distribution |
| 1 | Length 8 mm | In distribution |
| 1 | Length 18 mm | In distribution |
| 1 | Length 8 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | Length 48 mm | In distribution |
| 1 | Length 48 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Length 8 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 10 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Length 18 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Length 38 mm | In distribution |
| 1 | Length 12 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Length 14 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Length 44 mm | In distribution |
| 1 | Length 22 mm | In distribution |
| 1 | Length 14 mm | In distribution |
| 1 | Length 44 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 12 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 34 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 8 mm | In distribution |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn |
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 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213572 | 2022-01-18 |
| K172698 | 2018-02-07 |
Recalls Naming This Product
15 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 601 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 870 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 935 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 1302 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 1206 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 1574 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 24 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 52 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 156 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 30 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 2021-06-30 | |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 38 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 24 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 36 | 2021-06-30 |
| Orthofix US LLC | 510(k) number | 2018-04-06 | Class II | Device Design | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | 36 | 2021-06-30 |
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.