UniSyn® Hip System
Body, Standard, Cementless, NP, Grit Blast
13manufacturers in China registered for this device type
247catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
| 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 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Consensus Orthopedics, Inc., United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Record published | 2015-10-20 |
| Record revised | 2021-07-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 10 to 32 mm; length 30 to 55 mm |
| Distribution end date | 2021-07-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3461-22626-A | Outer Diameter 26 mm | Withdrawn |
| 3427-11615-0 | Outer Diameter 16 mm | Withdrawn |
| 3442-44538-A | Length 45 mm | Withdrawn |
| 3426-11917-0 | Outer Diameter 19 mm | Withdrawn |
| 3461-42434-0 | Outer Diameter 24 mm | Withdrawn |
| 3422-11515-0 | Outer Diameter 15 mm | Withdrawn |
| 3461-42622-A | Outer Diameter 26 mm | Withdrawn |
| 3442-45546-0 | Length 55 mm | Withdrawn |
| 3425-11421-0 | Outer Diameter 14 mm | Withdrawn |
| 3422-11921-0 | Outer Diameter 19 mm | Withdrawn |
| 3461-42626-0 | Outer Diameter 26 mm | Withdrawn |
| 3426-11619-0 | Outer Diameter 16 mm | Withdrawn |
| 3473-43000-0 | Outer Diameter 30 mm | Withdrawn |
| 3473-42600-A | Outer Diameter 26 mm | Withdrawn |
| 3473-42200-A | Outer Diameter 22 mm | Withdrawn |
| 3461-23034-A | Outer Diameter 30 mm | Withdrawn |
| 3426-11117-0 | Outer Diameter 11 mm | Withdrawn |
| 3441-13042-A | Length 30 mm | Withdrawn |
| 3461-23230-A | Outer Diameter 32 mm | Withdrawn |
| 3473-62800-A | Outer Diameter 28 mm | Withdrawn |
| 3425-11726-0 | Outer Diameter 17 mm | Withdrawn |
| 3461-22834-A | Outer Diameter 28 mm | Withdrawn |
| 3473-22200-0 | Outer Diameter 22 mm | Withdrawn |
| 3441-13034-0 | Length 30 mm | Withdrawn |
| 3461-53030-A | Outer Diameter 30 mm | Withdrawn |
| 3425-11521-0 | Outer Diameter 15 mm | Withdrawn |
| 3461-52422-A | Outer Diameter 24 mm | Withdrawn |
| 3425-11826-0 | Outer Diameter 18 mm | Withdrawn |
| 3460-42130-0 | Outer Diameter 21 mm | Withdrawn |
| 3461-42826-A | Outer Diameter 28 mm | Withdrawn |
| 3461-23030-A | Outer Diameter 30 mm | Withdrawn |
| 3461-42222-A | Outer Diameter 22 mm | Withdrawn |
| 3441-13638-0 | Length 36 mm | Withdrawn |
| 3422-11013-0 | Outer Diameter 10 mm | Withdrawn |
| 3461-22430-A | Outer Diameter 24 mm | Withdrawn |
| 3461-22826-A | Outer Diameter 28 mm | Withdrawn |
| 3449-04500-0 | Length 45 mm | Withdrawn |
| 3425-12026-0 | Outer Diameter 20 mm | Withdrawn |
| 3426-11013-0 | Outer Diameter 10 mm | Withdrawn |
| 3427-11213-0 | Outer Diameter 12 mm | Withdrawn |
| 3461-43026-0 | Outer Diameter 30 mm | Withdrawn |
| 3461-42222-0 | Outer Diameter 22 mm | Withdrawn |
| 3461-43030-A | Outer Diameter 30 mm | Withdrawn |
| 3425-11331-0 | Outer Diameter 13 mm | Withdrawn |
| 3473-42600-0 | Outer Diameter 26 mm | Withdrawn |
| 3461-52622-A | Outer Diameter 26 mm | Withdrawn |
| 3422-11716-0 | Outer Diameter 17 mm | Withdrawn |
| 3425-11326-0 | Outer Diameter 13 mm | Withdrawn |
| 3461-42622-0 | Outer Diameter 26 mm | Withdrawn |
| 3461-52834-A | Outer Diameter 28 mm | Withdrawn |
| 3461-53238-A | Outer Diameter 32 mm | Withdrawn |
| 3426-11113-0 | Outer Diameter 11 mm | Withdrawn |
| 3422-11318-0 | Outer Diameter 13 mm | Withdrawn |
| 3442-44546-A | Length 45 mm | Withdrawn |
| 3425-11431-0 | Outer Diameter 14 mm | Withdrawn |
| 3427-11314-0 | Outer Diameter 13 mm | Withdrawn |
| 3427-11720-0 | Outer Diameter 17 mm | Withdrawn |
| 3461-43234-A | Outer Diameter 32 mm | Withdrawn |
| 3427-11013-0 | Outer Diameter 10 mm | Withdrawn |
| 3426-11519-0 | Outer Diameter 15 mm | Withdrawn |
| 3441-13642-0 | Length 36 mm | Withdrawn |
| 3461-42422-0 | Outer Diameter 24 mm | Withdrawn |
| 3441-13646-A | Length 36 mm | Withdrawn |
| 3427-11820-0 | Outer Diameter 18 mm | Withdrawn |
| 3425-12131-0 | Outer Diameter 21 mm | Withdrawn |
| 3425-11426-0 | Outer Diameter 14 mm | Withdrawn |
| 3427-11619-0 | Outer Diameter 16 mm | Withdrawn |
| 3425-11821-0 | Outer Diameter 18 mm | Withdrawn |
| 3427-11414-0 | Outer Diameter 14 mm | Withdrawn |
| 3422-11720-0 | Outer Diameter 17 mm | Withdrawn |
| 3422-11619-0 | Outer Diameter 16 mm | Withdrawn |
| 3461-52634-A | Outer Diameter 26 mm | Withdrawn |
| 3461-42430-0 | Outer Diameter 24 mm | Withdrawn |
| 3461-52230-A | Outer Diameter 22 mm | Withdrawn |
| 3473-22600-0 | Outer Diameter 26 mm | Withdrawn |
| 3461-43238-A | Outer Diameter 32 mm | Withdrawn |
| 3425-12126-0 | Outer Diameter 21 mm | Withdrawn |
| 3461-42226-A | Outer Diameter 22 mm | Withdrawn |
| 3461-42426-A | Outer Diameter 24 mm | Withdrawn |
| 3427-11017-0 | Outer Diameter 10 mm | Withdrawn |
| 3460-41928-0 | Outer Diameter 19 mm | Withdrawn |
| 3473-23000-0 | Outer Diameter 30 mm | Withdrawn |
| 3461-52426-A | Outer Diameter 24 mm | Withdrawn |
| 3473-42400-A | Outer Diameter 24 mm | Withdrawn |
| 3426-11017-0 | Outer Diameter 10 mm | Withdrawn |
| 3461-42834-A | Outer Diameter 28 mm | Withdrawn |
| 3427-11515-0 | Outer Diameter 15 mm | Withdrawn |
| 3422-11017-0 | Outer Diameter 10 mm | Withdrawn |
| 3473-42800-0 | Outer Diameter 28 mm | Withdrawn |
| 3461-23038-A | Outer Diameter 30 mm | Withdrawn |
| 3473-62200-A | Outer Diameter 22 mm | Withdrawn |
| 3461-43038-A | Outer Diameter 30 mm | Withdrawn |
| 3427-12021-0 | Outer Diameter 20 mm | Withdrawn |
| 3461-43034-A | Outer Diameter 30 mm | Withdrawn |
| 3426-11314-0 | Outer Diameter 13 mm | Withdrawn |
| 3425-11526-0 | Outer Diameter 15 mm | Withdrawn |
| 3441-13046-0 | Length 30 mm | Withdrawn |
| 3441-13634-0 | Length 36 mm | Withdrawn |
| 3427-11816-0 | Outer Diameter 18 mm | Withdrawn |
| 3441-13042-0 | Length 30 mm | Withdrawn |
| 3422-11414-0 | Outer Diameter 14 mm | Withdrawn |
| 3461-42434-A | Outer Diameter 24 mm | Withdrawn |
| 3425-11721-0 | Outer Diameter 17 mm | Withdrawn |
| 3426-11414-0 | Outer Diameter 14 mm | Withdrawn |
| 3441-13046-A | Length 30 mm | Withdrawn |
| 3425-11926-0 | Outer Diameter 19 mm | Withdrawn |
| 3461-53034-A | Outer Diameter 30 mm | Withdrawn |
| 3422-11816-0 | Outer Diameter 18 mm | Withdrawn |
| 3425-11226-0 | Outer Diameter 12 mm | Withdrawn |
| 3461-42430-A | Outer Diameter 24 mm | Withdrawn |
| 3461-22634-A | Outer Diameter 26 mm | Withdrawn |
| 3425-11931-0 | Outer Diameter 19 mm | Withdrawn |
| 3422-12017-0 | Outer Diameter 20 mm | Withdrawn |
| 3461-43030-0 | Outer Diameter 30 mm | Withdrawn |
| 3460-41622-0 | Outer Diameter 17 mm | Withdrawn |
| 3422-11213-0 | Outer Diameter 12 mm | Withdrawn |
| 3425-11621-0 | Outer Diameter 16 mm | Withdrawn |
| 3461-23026-A | Outer Diameter 30 mm | Withdrawn |
| 3473-63000-A | Outer Diameter 30 mm | Withdrawn |
| 3441-13038-A | Length 30 mm | Withdrawn |
| 3442-45538-0 | Length 55 mm | Withdrawn |
| 3473-62600-A | Outer Diameter 26 mm | Withdrawn |
| 3461-52830-A | Outer Diameter 28 mm | Withdrawn |
| 3441-13642-A | Length 36 mm | Withdrawn |
| 3460-42128-0 | Outer Diameter 21 mm | Withdrawn |
| 3425-11126-0 | Outer Diameter 11 mm | Withdrawn |
| 3426-11418-0 | Outer Diameter 14 mm | Withdrawn |
| 3426-11820-0 | Outer Diameter 18 mm | Withdrawn |
| 3425-12121-0 | Outer Diameter 21 mm | Withdrawn |
| 3442-45534-0 | Length 55 mm | Withdrawn |
| 3461-52222-A | Outer Diameter 22 mm | Withdrawn |
| 3425-11631-0 | Outer Diameter 16 mm | Withdrawn |
| 3427-11117-0 | Outer Diameter 11 mm | Withdrawn |
| 3449-03600-0 | Length 36 mm | Withdrawn |
| 3425-12021-0 | Outer Diameter 20 mm | Withdrawn |
| 3425-11626-0 | Outer Diameter 16 mm | Withdrawn |
| 3461-42634-0 | Outer Diameter 26 mm | Withdrawn |
| 3427-11217-0 | Outer Diameter 12 mm | Withdrawn |
| 3460-42400-0 | Outer Diameter 17 mm | Withdrawn |
| 3449-05400-0 | Length 54 mm | Withdrawn |
| 3461-22630-A | Outer Diameter 26 mm | Withdrawn |
| 3473-42400-0 | Outer Diameter 24 mm | Withdrawn |
| 3426-11213-0 | Outer Diameter 12 mm | Withdrawn |
| 3425-11531-0 | Outer Diameter 15 mm | Withdrawn |
| 3422-11113-0 | Outer Diameter 11 mm | Withdrawn |
| 3461-43026-A | Outer Diameter 30 mm | Withdrawn |
| 3473-62400-A | Outer Diameter 24 mm | Withdrawn |
| 3461-42630-A | Outer Diameter 26 mm | Withdrawn |
| 3426-11921-0 | Outer Diameter 19 mm | Withdrawn |
| 3461-52626-A | Outer Diameter 26 mm | Withdrawn |
| 3473-22800-0 | Outer Diameter 28 mm | Withdrawn |
| 3461-42630-0 | Outer Diameter 26 mm | Withdrawn |
| 3426-11217-0 | Outer Diameter 12 mm | Withdrawn |
| 3422-11117-0 | Outer Diameter 11 mm | Withdrawn |
| 3425-11921-0 | Outer Diameter 19 mm | Withdrawn |
| 3460-42330-0 | Outer Diameter 23 mm | Withdrawn |
| 3426-11716-0 | Outer Diameter 17 mm | Withdrawn |
| 3427-11917-0 | Outer Diameter 19 mm | Withdrawn |
| 3422-11314-0 | Outer Diameter 13 mm | Withdrawn |
| 3460-41724-0 | Outer Diameter 17 mm | Withdrawn |
| 3461-23234-A | Outer Diameter 32 mm | Withdrawn |
| 3441-13034-A | Length 30 mm | Withdrawn |
| 3442-45534-A | Length 55 mm | Withdrawn |
| 3442-44534-A | Length 45 mm | Withdrawn |
| 3442-44546-0 | Length 45 mm | Withdrawn |
| 3461-42422-A | Outer Diameter 24 mm | Withdrawn |
| 3422-11217-0 | Outer Diameter 12 mm | Withdrawn |
| 3427-11921-0 | Outer Diameter 19 mm | Withdrawn |
| 3461-43230-A | Outer Diameter 32 mm | Withdrawn |
| 3460-42334-0 | Outer Diameter 17 mm | Withdrawn |
| 3461-52226-A | Outer Diameter 22 mm | Withdrawn |
| 3473-42200-0 | Outer Diameter 22 mm | Withdrawn |
| 3461-42830-A | Outer Diameter 28 mm | Withdrawn |
| 3427-11418-0 | Outer Diameter 14 mm | Withdrawn |
| 3427-11318-0 | Outer Diameter 13 mm | Withdrawn |
| 3461-42626-A | Outer Diameter 26 mm | Withdrawn |
| 3427-11113-0 | Outer Diameter 11 mm | Withdrawn |
| 3461-42634-A | Outer Diameter 26 mm | Withdrawn |
| 3422-11418-0 | Outer Diameter 14 mm | Withdrawn |
| 3441-13634-A | Length 36 mm | Withdrawn |
| 3426-11615-0 | Outer Diameter 16 mm | Withdrawn |
| 3461-22830-A | Outer Diameter 28 mm | Withdrawn |
| 3442-45542-A | Length 55 mm | Withdrawn |
| 3461-52826-A | Outer Diameter 28 mm | Withdrawn |
| 3461-42426-0 | Outer Diameter 24 mm | Withdrawn |
| 3442-45538-A | Length 55 mm | Withdrawn |
| 3473-43000-A | Outer Diameter 30 mm | Withdrawn |
| 3425-12031-0 | Outer Diameter 20 mm | Withdrawn |
| 3442-45542-0 | Length 55 mm | Withdrawn |
| 3461-22426-A | Outer Diameter 24 mm | Withdrawn |
| 3426-11720-0 | Outer Diameter 17 mm | Withdrawn |
| 3426-12017-0 | Outer Diameter 20 mm | Withdrawn |
| 3461-42226-0 | Outer Diameter 22 mm | Withdrawn |
| 3426-11318-0 | Outer Diameter 13 mm | Withdrawn |
| 3425-11731-0 | Outer Diameter 17 mm | Withdrawn |
| 3425-11021-0 | Outer Diameter 10 mm | Withdrawn |
| 3422-12021-0 | Outer Diameter 20 mm | Withdrawn |
| 3461-42826-0 | Outer Diameter 28 mm | Withdrawn |
| 3427-11716-0 | Outer Diameter 17 mm | Withdrawn |
| 3427-12017-0 | Outer Diameter 20 mm | Withdrawn |
| 3422-11615-0 | Outer Diameter 16 mm | Withdrawn |
| 3425-11231-0 | Outer Diameter 12 mm | Withdrawn |
| 3425-11026-0 | Outer Diameter 10 mm | Withdrawn |
| 3442-44538-0 | Length 45 mm | Withdrawn |
| 3461-23238-A | Outer Diameter 32 mm | Withdrawn |
| 3461-22422-A | Outer Diameter 24 mm | Withdrawn |
| 3473-22400-0 | Outer Diameter 24 mm | Withdrawn |
| 3461-22622-A | Outer Diameter 26 mm | Withdrawn |
| 3426-11515-0 | Outer Diameter 15 mm | Withdrawn |
| 3461-53234-A | Outer Diameter 32 mm | Withdrawn |
| 3441-13038-0 | Length 30 mm | Withdrawn |
| 3461-22434-A | Outer Diameter 24 mm | Withdrawn |
| 3461-53230-A | Outer Diameter 32 mm | Withdrawn |
| 3461-53038-A | Outer Diameter 30 mm | Withdrawn |
| 3442-44542-0 | Length 45 mm | Withdrawn |
| 3473-42800-A | Outer Diameter 28 mm | Withdrawn |
| 3461-42834-0 | Outer Diameter 28 mm | Withdrawn |
| 3461-42230-0 | Outer Diameter 22 mm | Withdrawn |
| 3461-42230-A | Outer Diameter 22 mm | Withdrawn |
| 3426-12021-0 | Outer Diameter 20 mm | Withdrawn |
| 3425-11121-0 | Outer Diameter 11 mm | Withdrawn |
| 3460-41624-0 | Outer Diameter 17 mm | Withdrawn |
| 3460-41722-0 | Outer Diameter 17 mm | Withdrawn |
| 3442-45546-A | Length 55 mm | Withdrawn |
| 3442-44534-0 | Length 45 mm | Withdrawn |
| 3425-11321-0 | Outer Diameter 13 mm | Withdrawn |
| 3461-22230-A | Outer Diameter 22 mm | Withdrawn |
| 3461-22222-A | Outer Diameter 22 mm | Withdrawn |
| 3461-43034-0 | Outer Diameter 30 mm | Withdrawn |
| 3442-44542-A | Length 45 mm | Withdrawn |
| 3422-11820-0 | Outer Diameter 18 mm | Withdrawn |
| 3427-11519-0 | Outer Diameter 15 mm | Withdrawn |
| 3441-13638-A | Length 36 mm | Withdrawn |
| 3461-42830-0 | Outer Diameter 28 mm | Withdrawn |
| 3461-52630-A | Outer Diameter 26 mm | Withdrawn |
| 3422-11519-0 | Outer Diameter 15 mm | Withdrawn |
| 3441-13646-0 | Length 36 mm | Withdrawn |
| 3461-22226-A | Outer Diameter 22 mm | Withdrawn |
| 3422-11917-0 | Outer Diameter 19 mm | Withdrawn |
| 3460-41924-0 | Outer Diameter 19 mm | Withdrawn |
| 3426-11816-0 | Outer Diameter 18 mm | Withdrawn |
| 3425-11831-0 | Outer Diameter 18 mm | Withdrawn |
| 3461-53026-A | Outer Diameter 30 mm | Withdrawn |
| 3461-52434-A | Outer Diameter 24 mm | Withdrawn |
| 3461-52430-A | Outer Diameter 24 mm | Withdrawn |
| 3425-11221-0 | Outer Diameter 12 mm | Withdrawn |
| 3449-03000-0 | Length 30 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 98 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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.