Evolution®
Evolution® KA Universal Thickness Caliper
8manufacturers in China registered for this device type
15catalogue 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 | Microport Orthopedics Inc., United States |
|---|---|
| FDA product code | KTZ |
| Device type | Caliper |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4150 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-30 |
| Record revised | 2018-03-29 (version 2) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E110011R | In distribution | |
| E110041L | In distribution | |
| E4001006 | In distribution | |
| E110041R | In distribution | |
| E110031R | In distribution | |
| E1500050 | In distribution | |
| E4001006CN | In distribution | |
| E1100103 | In distribution | |
| E1100131 | In distribution | |
| E1100201 | In distribution | |
| E1100132 | In distribution | |
| E1100101 | In distribution | |
| E110031L | In distribution | |
| E1100133 | In distribution | |
| E110011L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 17 |
| 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 |
| Caliper | Medtronic Sofamor Danek, Inc. | 6 |
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.