OrthoMedFlex
Pelion Stem, Standard Cemented - Size 1
7manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Orthomedflex LLC |
|---|---|
| FDA product code | MAY |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Premarket notification | Exempt |
| Record published | 2017-07-26 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 111162550 | In distribution | |
| 111162342 | In distribution | |
| 111162346 | In distribution | |
| 111162444 | In distribution | |
| 111162142 | In distribution | |
| 111162138 | In distribution | |
| 111162244 | In distribution | |
| 111162240 | In distribution | |
| 111162448 | In distribution | |
| 111162546 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument | Howmedica Osteonics Corp | 136 |
| Arcos Modular Revision System | Biomet Orthopedics | 48 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 40 |
| Ringloc HIP System | Biomet Orthopedics | 36 |
| Restoration | Howmedica Osteonics Corp | 29 |
| Arcos | Biomet Orthopedics | 19 |
| Echo® Bi-Metric® Hip System | Biomet Orthopedics | 18 |
| Trident | Howmedica Osteonics Corp | 12 |
| Arcos® STS™ Modular Revision System | Biomet Orthopedics | 10 |
| Ringloc Ranawat / Burstein HIP System | Biomet Orthopedics | 10 |
| Taperloc Complete Rasp/Provisional | Biomet Orthopedics | 9 |
| Regenerex® Ringloc®+ Hip System | Biomet Orthopedics | 9 |
Showing 12 of 40. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
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.