GAP Endo-EXO Medullary System
GAP CONICAL REAMER FOR Ø 4.8, 5.6, 6.4 mm NAILS
23manufacturers in China registered for this device type
14catalogue 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 | Orthopediatrics Canada ULC, Canada |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-13 |
| Record revised | 2025-05-13 (version 3) |
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 |
| Storage | Special storage condition: keep at room temperature |
| Sizes | Outer diameter 4.8 to 9.7 mm; lumen/inner diameter 2.15 to 2.2 mm; length 490 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GAP-DCA272 | Outer Diameter 7.2 mm | In distribution |
| GAP-DCA048 | Length 490 mm | In distribution |
| GAP-DCA264 | Outer Diameter 6.4 mm | In distribution |
| GAP-DLG255 | In distribution | |
| GAP-DTP200 | In distribution | |
| GAP-DCA256 | Outer Diameter 5.6 mm | In distribution |
| GAP-DCA056 | Length 490 mm | In distribution |
| GAP-DCA072 | Outer Diameter 7.4 mm | In distribution |
| GAP-DTP052 | Outer Diameter 9.7 mm | In distribution |
| GAP-DCA080 | Length 490 mm | In distribution |
| GAP-DTP101 | Outer Diameter 9.3 mm | In distribution |
| GAP-DCA248 | Outer Diameter 4.8 mm | In distribution |
| GAP-DCA280 | Outer Diameter 8.0 mm | In distribution |
| GAP-DCA064 | Length 490 mm | 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.