Inhance
Inhance Shoulder System ONE Step Prep Glenoid Reamer – Circular X-Large
9manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (2), Shanghai (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Jiangsu Kersen Medical Instrument Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 3 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | HWR |
| Device type | Driver, Prosthesis |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-30 |
| Record revised | 2023-10-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6205-60-060 | In distribution | |
| 6205-10-105 | In distribution | |
| 7505-10-103 | In distribution | |
| 6205-60-030 | In distribution | |
| 6201-01-151 | In distribution | |
| 6205-60-040 | In distribution | |
| 6105-30-040 | In distribution | |
| 6105-30-060 | In distribution | |
| 6205-60-050 | In distribution | |
| 6105-30-030 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Driver, Prosthesis | Depuy Spine, Inc. | 270 |
| ACE | Ace Surgical Supply Co., Inc. | 64 |
| Expedium | Medos International Sàrl | 54 |
| Moss | Depuy Spine, Inc. | 33 |
| Acumed | Acumed LLC | 24 |
| Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. | 23 |
| U2 Total Knee System | United Orthopedic Corp. | 23 |
| Driver, Prosthesis | Zimmer, Inc. | 22 |
| Viper | Depuy Spine, Inc. | 21 |
| X-Mesh | Depuy Spine, Inc. | 20 |
| Driver, Prosthesis | Depuy (Ireland) | 18 |
| Invictus | Alphatec Spine, Inc. | 18 |
Showing 12 of 390. All products under Driver, Prosthesis
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.