Journey
Journey II XR Tibial Orientation Stylus Right
8manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 4 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 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | KTZ |
| Device type | Caliper |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4150 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-11-20 |
| Record revised | 2023-09-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 74014466 | In distribution | |
| 71935182 | In distribution | |
| 74014465 | In distribution | |
| 71935181 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 17 |
| Evolution® | Microport Orthopedics Inc. | 15 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 13 |
| ACE | Ace Surgical Supply Co., Inc. | 11 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 10 |
| Zoll-Dental | Zoll-Dental | 10 |
| U2™ Knee | United Orthopedic Corp. | 9 |
| Advance® | Microport Orthopedics Inc. | 9 |
| Odyssey® | Microport Orthopedics Inc. | 9 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 9 |
| Invictus | Alphatec Spine, Inc. | 7 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 7 |
Showing 12 of 129. All products under Caliper
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.