Integra®
Integra® Humeral Resurfacing Arthroplasty Partially Threaded K-Wire is used for temporary fixation.
9manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Fujian (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | HXI |
| Device type | Passer, Wire, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-08-30 |
| Record revised | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2228611 | 3.937in L x.0433in diameter | In distribution |
| 605280230 | 230 mm L x 2.8 mm dia | In distribution |
| GDW-895-00 | 6.0 in L | In distribution |
| PN0920051001 | 4.0 in L x.094 in dia | In distribution |
| 2237811 | 3.937in L x.0620in diameter | In distribution |
| WIRE0930501T | 2.0mm | In distribution |
| WIRE0930501S | 2.0mm | In distribution |
| 605283230 | 230 mm L x 2.8 mm dia | In distribution |
| 605303230 | 3.0 mm dia x 230 mm L | Withdrawn |
| 605300230 | 3.0 mm dia x 230mm L | Withdrawn |
| 2227611 | 100 mm L x 1.1 mm dia | Withdrawn |
| 2227711 | 3.937 in L x.0433 in dia | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vilex Guidewire | Vilex IN Tennessee, Inc. | 51 |
| Baby Gorilla/Gorilla Plating System | Paragon 28 | 33 |
| Monster Screw System | Paragon 28 | 20 |
| Vilex Power Accessory | Vilex IN Tennessee, Inc. | 17 |
| Passer, Wire, Orthopedic | Integrity Implants, Inc. | 16 |
| In2Bones | IN2BONES USA, LLC | 14 |
| endophix | Suzhou Endophix Co., Ltd. | 14 |
| LineSider | Highridge Medical, LLC | 13 |
| Flower Orthopedics | Flower Orthopedics Corporation | 13 |
| Capture™ | Ascension Orthopedics, Inc. | 11 |
| Titanex | Vilex LLC | 10 |
| Evos Cabling System | Pioneer Surgical Technology, Inc. | 9 |
Showing 12 of 171. All products under Passer, Wire, Orthopedic
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.