Romeo Posterior Osteosynthesis System
Paddle Distractor
34manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (12), Zhejiang (10), Jiangsu (6). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Yee Hing Foon Plastic Co., Ltd. / Hope Come International | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zhejiang Beauty AND Health Electrical Appliance Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 3 |
| Raymond (Panyu Nansha) Electrical Appliances Development Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 2 |
| Ningbo Kaili Holding Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
Showing 12 of 34. All 34 manufacturers in China registered for Razor, Surgical
Record
| Listed by | Spineart SA, Switzerland |
|---|---|
| FDA product code | LWK |
| Device type | Razor, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-31 |
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, manufacturing date |
| Sizes | Height 3 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPE-IN 00 44-N | Height 05 mm | In distribution |
| SPE-IN 00 43-N | In distribution | |
| SPE-IN 00 42-N | Height 03 mm | In distribution |
| SPE-IN 00 45-N | Height 06 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Juliet ® Instrumentation | Spineart SA | 29 |
| 3M™ | 3M Company | 24 |
| Solventum™ | Solventum US LLC | 9 |
| Cardinal Health | Cardinal Health 200, LLC | 8 |
| DeRoyal | Deroyal Industries, Inc. | 5 |
| Razor, Surgical | Carefusion 2200, Inc. | 4 |
| Medline | Medline Industries, Inc. | 4 |
| SourceMark | Sourcemark, LLC. | 4 |
| Henry Schein | Henry Schein, Inc. | 2 |
| Twin Blade Razors | Dynarex Corp. | 1 |
| DawnMist | Dukal LLC | 1 |
| AMSafe® Prep Razor | Amsino Medical Inc. | 1 |
Showing 12 of 23. All products under Razor, Surgical
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.