CosmoLock Pedicle Screw System
Modular Tip, Bifid, Cross Offset, Right
8manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (3), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Qingdao Taniking Garment Co., Ltd. | Qingdao | Shandong | Manufacturer | 2 |
Record
| Listed by | Kalitec Direct, LLC, United States |
|---|---|
| FDA product code | HWN |
| Device type | Instrument, Compression |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Record published | 2018-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-K03-6012 | In distribution | |
| 11-K03-6010 | In distribution | |
| 10-K01-9700 | In distribution | |
| 11-K03-6015 | In distribution | |
| 11-K03-6013 | In distribution | |
| 11-K03-6014 | In distribution | |
| 11-K03-6011 | In distribution | |
| 11-K03-6008 | In distribution | |
| 10-K01-9610 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Compression | Synthes Gmbh | 78 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 42 |
| Invictus | Alphatec Spine, Inc. | 37 |
| Axle Interspinous Fusion System | Xtant Medical Holdings, Inc. | 35 |
| TrabecuLink Femoral and Tibial Cone – Instruments | Waldemar Link GmbH & Co. KG | 32 |
| Made-To-Order | Tornier Inc. | 28 |
| Instrument, Compression | Medtronic Sofamor Danek, Inc. | 20 |
| Tornier Flex | Tornier Inc. | 16 |
| General Instruments | Alphatec Spine, Inc. | 16 |
| Alpine XC Adjustable Fusion System | Highridge Medical, LLC | 14 |
| Coral | Seaspine Orthopedics Corporation | 12 |
| Apelo® / Apelo® MIS | Atlas Spine Inc. | 9 |
Showing 12 of 196. All products under Instrument, Compression
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.