Rival View Plating System – Reduce Fracture Plating System
RIVAL TI LAPIDUS PLATE LARGE 2MM STEP RIGHT (present record replaces device with Primary DI: 18053800893456
22manufacturers in China registered for this device type
61catalogue numbers in this listing
7510(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 | Orthofix SRL, Italy |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K140876 |
| Record published | 2019-10-31 |
| Record revised | 2025-11-20 (version 6) |
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 6 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 2 | In distribution | |
| 1 | In distribution | |
| 1 | hole centres distance: 18 mm. | In distribution |
| 1 | hole centres distance: 12 mm. | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 12 mm | In distribution |
| 1 | hole centres distance: 22 mm. | In distribution |
| 2 | In distribution | |
| 1 | In distribution | |
| 2 | Length 12 mm | In distribution |
| 2 | In distribution | |
| 1 | Length 6 mm | In distribution |
| 2 | In distribution | |
| 1 | hole centres distance: 30 mm. | In distribution |
| 2 | In distribution | |
| 1 | In distribution | |
| 2 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 2 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 2 | Length 18 mm | In distribution |
| 2 | Length 22 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 8 mm | In distribution |
| 2 | In distribution | |
| 1 | hole centres distance: 15 mm. | In distribution |
| 1 | In distribution | |
| 2 | In distribution | |
| 1 | In distribution | |
| 2 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 2 | Length 25 mm | In distribution |
| 1 | hole centres distance: 30 mm. | In distribution |
| 2 | In distribution | |
| 1 | Length 10 mm | In distribution |
| 1 | In distribution | |
| 1 | hole centres distance: 20 mm. | In distribution |
| 1 | hole centres distance: 25 mm. | In distribution |
| 2 | In distribution | |
| 1 | In distribution | |
| 2 | In distribution | |
| 2 | Length 12 mm | In distribution |
| 1 | In distribution | |
| 2 | In distribution | |
| 2 | In distribution | |
| 2 | Length 20 mm | In distribution |
| 2 | In distribution | |
| 2 | Length 15 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210157 | 2021-04-20 |
| K200246 | 2020-05-22 |
| K190388 | 2019-06-07 |
| K102201 | 2010-12-15 |
| K101936 | 2010-10-20 |
| K051945 | 2005-09-06 |
| K042766 | 2004-11-16 |
Recalls Naming This Product
20 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. | 50 | 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. | 100 | 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. | 50 | 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. | 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. | 54 | 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. | 75 | 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.