ROMEO2-Instruments Degen
Hook TIP - Right
8manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (3), Guangdong (1). 2 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 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Qingdao Taniking Garment Co., Ltd. | Qingdao | Shandong | Manufacturer | 2 |
Record
| Listed by | Spineart SA, Switzerland |
|---|---|
| FDA product code | HWN |
| Device type | Instrument, Compression |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-03-29 |
| Record revised | 2025-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPE-US 00 58-N | In distribution | |
| SPE-US 00 59-N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Compression | Synthes Gmbh | 78 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 42 |
| Invictus | Alphatec Spine, Inc. | 37 |
| Axle Interspinous Fusion System | Xtant Medical Holdings, Inc. | 35 |
| TrabecuLink Femoral and Tibial Cone – Instruments | Waldemar Link GmbH & Co. KG | 32 |
| Made-To-Order | Tornier Inc. | 28 |
| Instrument, Compression | Medtronic Sofamor Danek, Inc. | 20 |
| Tornier Flex | Tornier Inc. | 16 |
| General Instruments | Alphatec Spine, Inc. | 16 |
| Alpine XC Adjustable Fusion System | Highridge Medical, LLC | 14 |
| Coral | Seaspine Orthopedics Corporation | 12 |
| CosmoLock Pedicle Screw System | Kalitec Direct, LLC | 9 |
Showing 12 of 196. All products under Instrument, Compression
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.