Delta Xtend
Delta Xtend 145 RSA Goniometer
14manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | KQW |
| Device type | Goniometer, Nonpowered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.1520 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-06-04 |
| Record revised | 2020-07-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2307-01-131 | In distribution | |
| 2307-01-031 | 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 |
| 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 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 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.