Esop®
120 catalogue numbers from 245084 - ACETABULAR LINER/PE, Ø28 / Ø62, listed by Fournitures Hospitalieres Industrie, United States, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
120catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Fournitures Hospitalieres Industrie, United States |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| 510(k) | K961388 |
| Record published | 2015-10-24 |
| Record revised | 2020-09-09 (version 4) |
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 |
|---|---|---|
| 245084 – ACETABULAR LINER/PE, Ø28 / Ø62 | In distribution | |
| 245019 – ACETABULAR SHELL, Ø46 | In distribution | |
| 245256 – PE/LINER ANTI-DISLOCATION Ø28/Ø58 | In distribution | |
| 245251 – PE/LINER ANTI-DISLOCATION Ø22,22/Ø56 | In distribution | |
| 245048 – ACETABULAR LINER/PE, Ø22,22 / Ø68 | In distribution | |
| 201121 – DIAPHYSIS STEM, Ø13 | In distribution | |
| 265348 – 12/14 CEMENTLESS METAPHYSIS LEFT STEM, S13,75 | In distribution | |
| 265356 – 12/14 CEMENTLESS METAPHYSIS RIGHT STEM, S11,25 | In distribution | |
| 265352 – 12/14 CEMENTLESS METAPHYSIS LEFT STEM,S20 | In distribution | |
| 245022 – ACETABULAR SHELL, Ø52 | In distribution | |
| 245024 – ACETABULAR SHELL, Ø56 | In distribution | |
| 245224 – SCREW FOR IMPACTED SHELL, Ø6,5 / L70 | In distribution | |
| 245252 – PE/LINER ANTI-DISLOCATION Ø32/Ø56 | In distribution | |
| 245026 – ACETABULAR SHELL, Ø60 | In distribution | |
| 245037 – ACETABULAR LINER/PE, Ø22,22 / Ø46 | In distribution | |
| 245269 – PE/LINER ANTI-DISLOCATION, Ø22,22/Ø68 | In distribution | |
| 245241 – PE/LINER ANTI-DISLOCATION Ø28/Ø48 | In distribution | |
| 245248 – PE/LINER ANTI-DISLOCATION Ø22,22/Ø54 | In distribution | |
| 245075 – ACETABULAR LINER/PE, Ø28 / Ø56 | In distribution | |
| 201119 – DIAPHYSIS STEM, Ø11 | In distribution | |
| 245265 – PE/LINER ANTI-DISLOCATION Ø28/Ø64 | In distribution | |
| 245093 – ACETABULAR LINER/PE, Ø28 / Ø68 | In distribution | |
| 265360 – 12/14 CEMENTLESS METAPHYSIS RIGHT STEM, S16,25 | In distribution | |
| 245242 – PE/LINER ANTI-DISLOCATION Ø22,22/Ø50 | In distribution | |
| 265355 – 12/14 CEMENTLESS METAPHYSIS RIGHT STEM, S10 | In distribution | |
| 201118 – DIAPHYSIS STEM, Ø10 | In distribution | |
| 245041 – ACETABULAR LINER/PE, Ø22,22 / Ø54 | In distribution | |
| 256240 – DIAPHYSEAL TIP, Ø13 | In distribution | |
| 245260 – PE/LINER ANTI-DISLOCATION, Ø22,22/Ø62 | In distribution | |
| 245221 – SCREW FOR IMPACTED SHELL, Ø6,5 / L45 | In distribution | |
| 245079 – ACETABULAR LINER/PE, Ø32 / Ø58 | In distribution | |
| 245257 – PE/LINER ANTI-DISLOCATION Ø22,22/Ø60 | In distribution | |
| 245094 – ACETABULAR LINER/PE, Ø32 / Ø68 | In distribution | |
| 245029 – ACETABULAR SHELL, Ø66 | In distribution | |
| 245028 – ACETABULAR SHELL, Ø64 | In distribution | |
| 245020 – ACETABULAR SHELL, Ø48 | In distribution | |
| 245267 – PE/LINER ANTI-DISLOCATION, Ø32/Ø66 | In distribution | |
| 245215 – SCREW FOR IMPACTED SHELL, Ø6,5 / L15 | In distribution | |
| 265354 – 12/14 CEMENTLESS METAPHYSIS RIGHT STEM, S7,5 | In distribution | |
| 245244 – PE/LINER ANTI-DISLOCATION , Ø28/Ø50 | In distribution | |
| 245254 – PE/LINER ANTI-DISLOCATION Ø22,22/Ø58 | In distribution | |
| 265345 – 12/14 CEMENTLESS METAPHYSIS LEFT STEM, S10 | In distribution | |
| 245263 – PE/LINER ANTI-DISLOCATION, Ø22,22/Ø64 | In distribution | |
| 245091 – ACETABULAR LINER/PE, Ø32 / Ø66 | In distribution | |
| 245070 – ACETABULAR LINER/PE, Ø32 / Ø52 | In distribution | |
| 245044 – ACETABULAR LINER/PE, Ø22,22 / Ø60 | In distribution | |
| 245038 – ACETABULAR LINER/PE, Ø22,22 / Ø48 | In distribution | |
| 245264 – PE/LINER ANTI-DISLOCATION, Ø32/Ø64 | In distribution | |
| 265344 – 12/14 CEMENTLESS METAPHYSIS LEFT STEM, S7,5 | In distribution | |
| 245271 – PE/LINER ANTI-DISLOCATION, Ø32/Ø68 | In distribution | |
| 245270 – PE/LINER ANTI-DISLOCATION, Ø28/Ø68 | In distribution | |
| 265358 – 12/14 CEMENTLESS METAPHYSIS RIGHT STEM, S13,75 | In distribution | |
| 245090 – ACETABULAR LINER/PE, Ø28 / Ø66 | In distribution | |
| 265347 – 12/14 CEMENTLESS METAPHYSIS LEFT STEM, S12,5 | In distribution | |
| 245239 – PE/LINER ANTI-DISLOCATION Ø28/Ø46 | In distribution | |
| 245021 – ACETABULAR SHELL, Ø50 | In distribution | |
| 201117 – DIAPHYSIS STEM, Ø9 | In distribution | |
| 245245 – PE/LINER ANTI-DISLOCATION Ø22,22/Ø52 | In distribution | |
| 245261 – PE/LINER ANTI-DISLOCATION, Ø32/Ø62 | In distribution | |
| 265359 – 12/14 CEMENTLESS METAPHYSIS RIGHT STEM, S15 | In distribution | |
| 245023 – ACETABULAR SHELL, Ø54 | In distribution | |
| 201120 – DIAPHYSIS STEM, Ø12 | In distribution | |
| 245249 – PE/LINER ANTI-DISLOCATION Ø32/Ø54 | In distribution | |
| 245219 – SCREW FOR IMPACTED SHELL, Ø6,5 / L35 | In distribution | |
| 245043 – ACETABULAR LINER/PE, Ø22,22 / Ø58 | In distribution | |
| 265349 – 12/14 CEMENTLESS METAPHYSIS LEFT STEM,S15, | In distribution | |
| 245064 – ACETABULAR LINER/PE, Ø28 / Ø48 | In distribution | |
| 245072 – ACETABULAR LINER/PE, Ø28 / Ø54 | In distribution | |
| 245266 – PE/LINER ANTI-DISLOCATION, Ø22,22/Ø66 | In distribution | |
| 245087 – ACETABULAR LINER/PE, Ø28 / Ø64 | In distribution | |
| 245073 – ACETABULAR LINER/PE, Ø32 / Ø54 | In distribution | |
| 203605 – DIAPHYSIS STEM, Ø14 | In distribution | |
| 265343 – 12/14 CEMENTLESS METAPHYSIS LEFT STEM, S5 | In distribution | |
| 245218 – SCREW FOR IMPACTED SHELL, Ø6,5 / L30 | In distribution | |
| 256238 – DIAPHYSEAL TIP, Ø11 | In distribution | |
| 245253 – PE/LINER ANTI-DISLOCATION, Ø28/Ø56 | In distribution | |
| 245046 – ACETABULAR LINER/PE, Ø22,22 / Ø64 | In distribution | |
| 245042 – ACETABULAR LINER/PE, Ø22,22 / Ø56 | In distribution | |
| 245216 – SCREW FOR IMPACTED SHELL, Ø6,5 / L20 | In distribution | |
| 245047 – ACETABULAR LINER/PE, Ø22,22 / Ø66 | In distribution | |
| 245246 – PE/LINER ANTI-DISLOCATION Ø32/Ø52 | In distribution | |
| 245076 – ACETABULAR LINER/PE, Ø32 / Ø56 | In distribution | |
| 245258 – PE/LINER ANTI-DISLOCATION Ø32/Ø60 | In distribution | |
| 265346 – 12/14 CEMENTLESS METAPHYSIS LEFT STEM, S11,25 | In distribution | |
| 245262 – PE/LINER ANTI-DISLOCATION, Ø28/Ø62 | In distribution | |
| 245082 – ACETABULAR LINER/PE, Ø32 / Ø60 | In distribution | |
| 245069 – ACETABULAR LINER/PE, Ø28 / Ø52 | In distribution | |
| 245220 – SCREW FOR IMPACTED SHELL, Ø6,5 / L40 | In distribution | |
| 245217 – SCREW FOR IMPACTED SHELL, Ø6,5 / L25 | In distribution | |
| 245222 – SCREW FOR IMPACTED SHELL, Ø6,5 / L50 | In distribution | |
| 245045 – ACETABULAR LINER/PE, Ø22,22 / Ø62 | In distribution | |
| 245223 – SCREW FOR IMPACTED SHELL, Ø6,5 / L60 | In distribution | |
| 245259 – PE/LINER ANTI-DISLOCATION Ø28/Ø60 | In distribution | |
| 265350 – 12/14 CEMENTLESS METAPHYSIS LEFT STEM,S16,25 | In distribution | |
| 265362 – 12/14 CEMENTLESS METAPHYSIS RIGHT STEM, S20 | In distribution | |
| 245250 -PE/LINER ANTI-DISLOCATION Ø28/Ø54 | In distribution | |
| 203606 – DIAPHYSIS STEM, Ø15 | In distribution | |
| 265351 – 12/14 CEMENTLESS METAPHYSIS LEFT STEM, S17,5 | In distribution | |
| 265361 – 12/14 CEMENTLESS METAPHYSIS RIGHT STEM, S17,5 | In distribution | |
| 245078 – ACETABULAR LINER/PE, Ø28 / Ø58 | In distribution | |
| 245085 – ACETABULAR LINER/PE, Ø32 / Ø62 | In distribution | |
| 265353 – 12/14 CEMENTLESS METAPHYSIS RIGHT STEM, S5 | In distribution | |
| 245066 – ACETABULAR LINER/PE, Ø28 / Ø50 | In distribution | |
| 245025 – ACETABULAR SHELL, Ø58 | In distribution | |
| 256239 – DIAPHYSEAL TIP, Ø12 | In distribution | |
| 245039 – ACETABULAR LINER/PE, Ø22,22 / Ø50 | In distribution | |
| 245040 – ACETABULAR LINER/PE, Ø22,22 / Ø52 | In distribution | |
| 245247 – PE/LINER ANTI-DISLOCATION Ø28/Ø52 | In distribution | |
| 245243 – PE/LINER ANTI-DISLOCATION Ø32/Ø50 | In distribution | |
| 245238 – PE/LINER ANTI-DISLOCATION Ø22,22/Ø46 | In distribution | |
| 245030 – ACETABULAR SHELL, Ø68 | In distribution | |
| 245081 – ACETABULAR LINER/PE, Ø28 / Ø60 | In distribution | |
| 265357 – 12/14 CEMENTLESS METAPHYSIS RIGHT STEM, S12,5 | In distribution | |
| 245268 – PE/LINER ANTI-DISLOCATION, Ø28/Ø66 | In distribution | |
| 245067 – ACETABULAR LINER/PE, Ø32 / Ø50 | In distribution | |
| 245062 – ACETABULAR LINER/PE, Ø28 / Ø46 | In distribution | |
| 245240 -PE/LINER ANTI-DISLOCATION Ø22,22/Ø48 | In distribution | |
| 245255 – PE/LINER ANTI-DISLOCATION Ø32/Ø58 | In distribution | |
| 245088 – ACETABULAR LINER/PE, Ø32 / Ø64 | In distribution | |
| 245027 – ACETABULAR SHELL, Ø62 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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.