Avenger
Avenger Radial Head Stem Implant,Size Dia. 6.5 x 16 mm,+4mm
3manufacturers in China registered for this device type
32catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | IN2BONES USA, LLC, United States |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K192754 |
| Record published | 2020-02-21 |
| Record revised | 2025-08-04 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M70 SC075 | In distribution | |
| M70 SC355 | In distribution | |
| M70 SC155 | In distribution | |
| M70 SC385 | In distribution | |
| M70 HC022 | In distribution | |
| M70 HC122 | In distribution | |
| M70 HC120 | In distribution | |
| M70 SC185 | In distribution | |
| M70 HC024 | In distribution | |
| M70 SC255 | In distribution | |
| M70 SC195 | In distribution | |
| M70 HC118 | In distribution | |
| M70 HC222 | In distribution | |
| M70 HC224 | In distribution | |
| M70 SC095 | In distribution | |
| M70 SC165 | In distribution | |
| M70 SC285 | In distribution | |
| M70 HC220 | In distribution | |
| M70 SC055 | In distribution | |
| M70 SC395 | In distribution | |
| M70 HC020 | In distribution | |
| M70 SC275 | In distribution | |
| M70 SC295 | In distribution | |
| M70 SC365 | In distribution | |
| M70 HC124 | In distribution | |
| M70 SC175 | In distribution | |
| M70 HC218 | In distribution | |
| M70 SC085 | In distribution | |
| M70 SC265 | In distribution | |
| M70 HC018 | In distribution | |
| M70 SC375 | In distribution | |
| M70 SC065 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acumed | Acumed LLC | 175 |
| Align | Skeletal Dynamics L.L.C. | 97 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes (U.S.A.) LP | 78 |
| Evolve | Wright Medical Technology, Inc. | 75 |
| Rhead | Stryker GmbH | 53 |
| L2L™ | Zimmer, Inc. | 48 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes Gmbh | 43 |
| Explor | Biomet Orthopedics | 32 |
| BioPoly® Radial Head Implant | Biopoly, LLC | 30 |
| Seitz Solution Radial Head | Kapp Surgical Instrument, Inc. | 27 |
| Integra® | Ascension Orthopedics, Inc. | 23 |
| Modular Radial Head (MRH) System | Smith & Nephew, Inc. | 22 |
Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212872 | 2021-12-17 |
| K192754 | 2020-01-07 |
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.