Apex 3d Total Ankle Replacement System
APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Right, Size 2
23manufacturers in China registered for this device type
37catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Zhejiang (3). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Changzhou Master Precision Tool Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Showing 12 of 23. All 23 manufacturers in China registered for Reamer
Record
| Listed by | Paragon 28, United States |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-14 |
| Record revised | 2025-04-22 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P10-851-TPL1 | In distribution | |
| P10-951-TPR2 | In distribution | |
| P10-951-TPL3 | In distribution | |
| P10-951-TPL2 | In distribution | |
| P10-944-4013 | In distribution | |
| P10-851-TPR2 | In distribution | |
| P10-951-TPR5 | In distribution | |
| P10-944-0975 | In distribution | |
| P10-951-TPL6 | In distribution | |
| P10-851-TPL3 | In distribution | |
| P10-951-TPR1 | In distribution | |
| P10-851-TPR1 | In distribution | |
| P10-951-TPR4 | In distribution | |
| P10-851-TPL2 | In distribution | |
| P10-851-TPR4 | In distribution | |
| P10-851-TPR3 | In distribution | |
| P10-951-TPR3 | In distribution | |
| P10-944-1375 | In distribution | |
| P10-944-1175 | In distribution | |
| P10-851-TBV4 | In distribution | |
| P10-851-TPL5 | In distribution | |
| P10-951-TPR6 | In distribution | |
| P10-951-TPL4 | In distribution | |
| P10-920-TLRM | In distribution | |
| P10-951-PPL1 | In distribution | |
| P10-851-TPL4 | In distribution | |
| P10-851-TPR5 | In distribution | |
| P10-951-TPL1 | In distribution | |
| P10-851-TBV5 | In distribution | |
| P10-851-TBV6 | In distribution | |
| P10-851-TPL6 | In distribution | |
| P10-851-TBV2 | In distribution | |
| P10-851-TBV1 | In distribution | |
| P10-851-TPR6 | In distribution | |
| P10-951-TPL5 | In distribution | |
| P10-851-TBV3 | In distribution | |
| P10-951-PPR1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trigen | Smith & Nephew, Inc. | 1,029 |
| Viant Medical, LLC | Viant Medical, LLC | 825 |
| R3 | Smith & Nephew, Inc. | 287 |
| Reamer | Ortho Development Corp. | 259 |
| InSitu Hip System | Nextstep Arthropedix | 181 |
| Apex Knee System | Omni Life Science, Inc. | 162 |
| Reamer | Synthes Gmbh | 152 |
| Reclaim | Depuy (Ireland) | 138 |
| Reamer | Zimmer, Inc. | 135 |
| Endo-Model Knee System – Instruments | Waldemar Link GmbH & Co. KG | 109 |
| DJO Surgical | Encore Medical, L.P. | 108 |
| Arthrex® | Arthrex, Inc. | 105 |
Showing 12 of 1,224. All products under Reamer
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.