R3
R3 Anti-Rotation TIP W/Flat SZ66/70MM
18manufacturers in China registered for this device type
153catalogue 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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HWA |
| Device type | Impactor |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-11-13 |
| Record revised | 2026-02-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E0018204-1 | In distribution | |
| E0017634-5 | In distribution | |
| E0017364-1 | In distribution | |
| E0015562-10 | In distribution | |
| E0017000-6 | In distribution | |
| E0015591-6 | In distribution | |
| E0016375-2 | In distribution | |
| E0018009-4 | In distribution | |
| E0017926-1 | In distribution | |
| E0015259-1 | In distribution | |
| E0018029-1 | In distribution | |
| E0017930-1 | In distribution | |
| E0018093-1 | In distribution | |
| E0018273-8 | In distribution | |
| E0016448-2 | In distribution | |
| E0015562-13 | In distribution | |
| E0016585-1 | In distribution | |
| E0017926-2 | In distribution | |
| E0016375-1 | In distribution | |
| E0017634-4 | In distribution | |
| E0015591-14 | In distribution | |
| E0016071-1 | In distribution | |
| E0015841-2 | In distribution | |
| E0017612-6 | In distribution | |
| E0017245-1 | In distribution | |
| E0017026-5 | In distribution | |
| E0017537-1 | In distribution | |
| E0016241-14 | In distribution | |
| E0015591-12 | In distribution | |
| E0018100-1 | In distribution | |
| E0016917-2 | In distribution | |
| E0016448-4 | In distribution | |
| E0017026-6 | In distribution | |
| E0016206-1 | In distribution | |
| E0016708-1 | In distribution | |
| E0016129-1 | In distribution | |
| E0015502-1 | In distribution | |
| E0018130-1 | In distribution | |
| E0018009-6 | In distribution | |
| E0016053-2 | In distribution | |
| E0017970-1 | In distribution | |
| E0017634-2 | In distribution | |
| E0016800-1 | In distribution | |
| E0018009-3 | In distribution | |
| E0018009-2 | In distribution | |
| E0015562-14 | In distribution | |
| E0017199-1 | In distribution | |
| E0018081-1 | In distribution | |
| E0015271-1 | In distribution | |
| E0016493-8 | In distribution | |
| E0017026-2 | In distribution | |
| E0016585-2 | In distribution | |
| E0015763-1 | In distribution | |
| E0016211-1 | In distribution | |
| E0017000-3 | In distribution | |
| E0016448-3 | In distribution | |
| E0018009-11 | In distribution | |
| E0017463-1 | In distribution | |
| E0016241-10 | In distribution | |
| E0016448-5 | In distribution | |
| E0017000-8 | In distribution | |
| E0016217-1 | In distribution | |
| E0018273-6 | In distribution | |
| E0017245-2 | In distribution | |
| E0015562-11 | In distribution | |
| E0016917-1 | In distribution | |
| E0018009-5 | In distribution | |
| E0017634-8 | In distribution | |
| E0018273-7 | In distribution | |
| E0015562-12 | In distribution | |
| E0016613-1 | In distribution | |
| E0018009-1 | In distribution | |
| E0016217-2 | In distribution | |
| E0015841-1 | In distribution | |
| E0016249-1 | In distribution | |
| E0017634-7 | In distribution | |
| E0017920-2 | In distribution | |
| E0018009-9 | In distribution | |
| E0017612-3 | In distribution | |
| E0017634-1 | In distribution | |
| E0017809-1 | In distribution | |
| E0015591-10 | In distribution | |
| E0018243-1 | In distribution | |
| E0017770-1 | In distribution | |
| E0018009-12 | In distribution | |
| E0017612-10 | In distribution | |
| E0018273-4 | In distribution | |
| E0018009-8 | In distribution | |
| E0018273-1 | In distribution | |
| E0017729-1 | In distribution | |
| E0017130-1 | In distribution | |
| E0017199-2 | In distribution | |
| E0016170-1 | In distribution | |
| E0016025-1 | In distribution | |
| E0017588-1 | In distribution | |
| E0017943-1 | In distribution | |
| E0017033-1 | In distribution | |
| E0016286-1 | In distribution | |
| E0017026-7 | In distribution | |
| E0015591-11 | In distribution | |
| E0017948-1 | In distribution | |
| E0016448-6 | In distribution | |
| E0017612-1 | In distribution | |
| E0016928-1 | In distribution | |
| E0017634-3 | In distribution | |
| E0017418-1 | In distribution | |
| E0017612-5 | In distribution | |
| E0018099-1 | In distribution | |
| E0018009-7 | In distribution | |
| E0016241-6 | In distribution | |
| E0017026-8 | In distribution | |
| E0016241-11 | In distribution | |
| E0017253-1 | In distribution | |
| E0016241-12 | In distribution | |
| E0017000-5 | In distribution | |
| E0017000-4 | In distribution | |
| E0017612-8 | In distribution | |
| E0015591-13 | In distribution | |
| E0018101-1 | In distribution | |
| E0017612-2 | In distribution | |
| E0017920-1 | In distribution | |
| E0017612-7 | In distribution | |
| E0017245-4 | In distribution | |
| E0017000-7 | In distribution | |
| E0018273-3 | In distribution | |
| E0018009-10 | In distribution | |
| E0015562-6 | In distribution | |
| E0018273-5 | In distribution | |
| E0016448-7 | In distribution | |
| E0018183-1 | In distribution | |
| E0016613-2 | In distribution | |
| E0016448-8 | In distribution | |
| E0016053-1 | In distribution | |
| E0017000-1 | In distribution | |
| E0017612-4 | In distribution | |
| E0015873-1 | In distribution | |
| E0017000-2 | In distribution | |
| E0017026-4 | In distribution | |
| E0016761-1 | In distribution | |
| E0017026-3 | In distribution | |
| E0017612-9 | In distribution | |
| E0016448-1 | In distribution | |
| E0015763-2 | In distribution | |
| E0016241-13 | In distribution | |
| E0017301-1 | In distribution | |
| E0017625-1 | In distribution | |
| E0016603-1 | In distribution | |
| E0017634-6 | In distribution | |
| E0017026-1 | In distribution | |
| E0018266-1 | In distribution | |
| E0014695-1 | Withdrawn | |
| E0014522-1 | Withdrawn | |
| E0014522 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Attune | Depuy (Ireland) | 31 |
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.