U2 Acetabular Components, HA/Ti Plasma Spray
U2 Acetabular cup, HA/Ti plasma spray, Ø74mm
9manufacturers in China registered for this device type
16catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K050262 |
| Record published | 2015-10-24 |
| Record revised | 2018-08-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 44 to 74 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1303-5274 | Outer Diameter 74 mm | In distribution |
| 1303-5266 | Outer Diameter 66 mm | In distribution |
| 1303-5258 | Outer Diameter 58 mm | In distribution |
| 1303-5264 | Outer Diameter 64 mm | In distribution |
| 1303-5262 | Outer Diameter 62 mm | In distribution |
| 1303-5244 | Outer Diameter 44 mm | In distribution |
| 1303-5254 | Outer Diameter 54 mm | In distribution |
| 1303-5268 | Outer Diameter 68 mm | In distribution |
| 1303-5272 | Outer Diameter 72 mm | In distribution |
| 1303-5246 | Outer Diameter 46 mm | In distribution |
| 1303-5250 | Outer Diameter 50 mm | In distribution |
| 1303-5252 | Outer Diameter 52 mm | In distribution |
| 1303-5260 | Outer Diameter 60 mm | In distribution |
| 1303-5270 | Outer Diameter 70 mm | In distribution |
| 1303-5248 | Outer Diameter 48 mm | In distribution |
| 1303-5256 | Outer Diameter 56 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062978 | 2007-01-16 |
| K050262 | 2005-08-15 |
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.