Integra® Miltex®
Integra® Miltex® Polk Finger Goniometer, 5-3/4", Graduated in Inches and Centimeters
14manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (3), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| GuoLong (Shenzhen) High Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Guangzhou Goldsun Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Ningbo Magic Time Medical Equipment Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 2 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Guangdong Hexin Technology Weaving Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 17 |
| Hangzhou Tuopusi Medical Products Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 16 |
| Wenzhou Longwan Medical Device Factory | Wenzhou | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 14. All 14 manufacturers in China registered for Goniometer, Nonpowered
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | KQW |
| Device type | Goniometer, Nonpowered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.1520 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-12 |
| Record revised | 2023-04-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 27-144 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| mymobility® Platform | Zimmer Us, Inc. | 37 |
| Pyrenees® Cervical Plate System | VB Spine LLC | 11 |
| Lumex | GF Health Products, Inc | 4 |
| gSource | Gsource, LLC. | 4 |
| Regatta® Plate | Seaspine Orthopedics Corporation | 3 |
| ADC® | American Diagnostic Corp. | 3 |
| Delta Xtend | Depuy (Ireland) | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Goniometer, Nonpowered | Smith & Nephew, Inc. | 2 |
| Ambler Surgical | Ambler Surgical, LLC | 2 |
| Lafayette Extendable Goniometer | Lafayette Instrument Co., Inc. | 1 |
| CanarE → Clinic Wearable Device | Canary Medical USA LLC | 1 |
Showing 12 of 39. All products under Goniometer, Nonpowered
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.