Millennium
Malleable Bone Imapacting Grafter Extra Small, OA 11.4" Shaft Length 5.9" Diameter 6.5mm
18manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Shandong (2). 7 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| 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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Showing 12 of 18. All 18 manufacturers in China registered for Impactor
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | HWA |
| Device type | Impactor |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-17 |
| Record revised | 2026-02-09 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1-529601 | In distribution | |
| 1-59116 | In distribution | |
| 0-69980 | In distribution | |
| 12-281000 | In distribution | |
| 16-111007 | In distribution | |
| 6-6541 | In distribution | |
| 1-S7587M | In distribution | |
| 1-OS4341002 | In distribution | |
| 85-58001093 | In distribution | |
| 16-111005 | In distribution | |
| 12-463007 | In distribution | |
| 6-6545 | In distribution | |
| 25-771022 | In distribution | |
| 6-6547 | In distribution | |
| 85-2496501 | In distribution | |
| 1-529602 | In distribution | |
| 1-NL9115 | In distribution | |
| 6-6543 | In distribution | |
| 72-230316 | In distribution | |
| 6-6546 | In distribution | |
| 9-57100019 | In distribution | |
| 16-111001 | In distribution | |
| 16-110991 | In distribution | |
| 1-5334 | In distribution | |
| 16-111003 | In distribution | |
| 6-6548 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 153 |
| Conserve® | Microport Orthopedics Inc. | 76 |
| DJO Surgical | Encore Medical, L.P. | 73 |
| Impactor | Synthes Gmbh | 56 |
| Innomed, Inc. | Innomed, Inc. | 53 |
| Impactor | Zimmer, Inc. | 50 |
| Impactor | Zimmer Trabecular Metal Technology, Inc. | 43 |
| iNSitu™ Hip System | Nextstep Arthropedix | 41 |
| Apex Knee System | Omni Life Science, Inc. | 40 |
| DJO Surgical | DJO, LLC | 36 |
| Evolution® | Microport Orthopedics Inc. | 35 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 35 |
Showing 12 of 825. All products under Impactor
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.