Revolution External Plating System
Slotted 90° Tubular Wrench x 10mm
17manufacturers in China registered for this device type
42catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Record
| Listed by | Metalogix |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K181630 |
| Record published | 2019-08-07 |
| Record revised | 2025-05-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Length 3.89 to 20.9 in; width 6.4 to 11.1 in; height 5.5 to 10.2 in; depth 1.4 to 2 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900128-F | Depth 2.0 in | In distribution |
| 623060 | Thread Length: 60mm | In distribution |
| 617050 | Thread Length: 50mm | In distribution |
| 900127-F | Height 10.1 in | In distribution |
| 618030 | Thread Length: 30mm | In distribution |
| 620040 | Thread Length: 40mm | In distribution |
| 622050 | Thread Length: 50mm | In distribution |
| 623070 | Diameter: 6mm | In distribution |
| 623040 | Diameter: 6mm | In distribution |
| 623080 | Diameter: 6mm | In distribution |
| 617015 | Thread Length: 20mm | In distribution |
| 900104 | Slotted 90° | In distribution |
| 620060 | Thread Length: 60mm | In distribution |
| 623050 | Thread Length: 6mm | In distribution |
| 621030 | Thread Length: 30mm | In distribution |
| 622060 | Thread Length: 60mm | In distribution |
| 622080 | Thread Length: 80mm | In distribution |
| 900105 | Open End/Swivel End | In distribution |
| 900117 | Length 16.93 in | In distribution |
| 621060 | Thread Length: 60mm | In distribution |
| 624005 | Diameter: 5mm | In distribution |
| 620080 | Thread Length: 80mm | In distribution |
| 618050 | Thread Length: 50mm | In distribution |
| 900103 | In distribution | |
| 900125-F | Height 9.6 in | In distribution |
| 900106 | Standard | In distribution |
| 900129-F | Depth 1.4 in | In distribution |
| 621040 | Thread Length: 40mm | In distribution |
| 100404 | 4-6mm | In distribution |
| 624004 | Diameter: 4mm | In distribution |
| 620030 | Thread Length: 30mm | In distribution |
| 618015 | Thread Length: 20mm | In distribution |
| 622070 | Diameter: 6mm | In distribution |
| 900123-F | Width 10.3 in | In distribution |
| 900100 | In distribution | |
| 617030 | Thread Length: 30mm | In distribution |
| 622040 | Thread Length: 40mm | In distribution |
| 900217 | Length 16.93 in | In distribution |
| 900126-F | Height 5.5 in | In distribution |
| 900124-F | Height 10.1 in | In distribution |
| 621080 | Thread Length: 80mm | In distribution |
| 624006 | Diameter: 6mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Correction | Wishbone Medical Inc. | 1,534 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Synthes Gmbh | 880 |
| LCP | Synthes Gmbh | 355 |
| Orthex External Fixation System | Orthopediatrics, Corp | 353 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Sterilmed, Inc. | 325 |
| CHS | Smith & Nephew, Inc. | 321 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker Sustainability Solutions | 277 |
| Hoffmann | Stryker GmbH | 239 |
| Orthex | Orthopediatrics, Corp | 231 |
| Orthex | Vilex IN Tennessee, Inc. | 221 |
| Omega | Stryker GmbH | 212 |
| eZ-Fix | Orthopediatrics, Corp | 207 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|
| Fusion Orthopedics USA, LLC | 510(k) number | 2020-12-28 | Class II | Device Design | Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery. | 410 total devices |
| Fusion Orthopedics USA, LLC | 510(k) number | 2020-06-08 | Class II | Device Design | 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage. | 426 |
| Fusion Orthopedics USA, LLC | 510(k) number | 2019-07-23 | Class II | Under Investigation by firm | The threads on posts stripping out when tensioned during application process. | 222 units |
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.