CD Horizon™ ModuLeX™ Spinal System
Tray 5597822 NS LNG ROD 5.0-HYPERK Lower
5manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), 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 |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| 510(k) | K190840 |
| Record published | 2022-11-04 |
| Record revised | 2022-09-16 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5597822 | In distribution | |
| 5598910 | In distribution | |
| 5598907 | In distribution | |
| 5597800 | In distribution | |
| 5598900 | In distribution | |
| 5598902 | In distribution | |
| 5598922 | In distribution | |
| 5597902 | In distribution | |
| 5598923 | In distribution | |
| 5598918 | In distribution | |
| 5598934 | In distribution | |
| 5598911 | In distribution | |
| 5598921 | In distribution | |
| 5598932 | In distribution | |
| 5598938 | In distribution | |
| 5598929 | In distribution | |
| NAV5597903 | In distribution | |
| 5597821 | In distribution | |
| 5598908 | In distribution | |
| 5598930 | In distribution | |
| 5598939 | In distribution | |
| 5597819 | In distribution | |
| 5598912 | In distribution | |
| 5597801 | In distribution | |
| 5597825 | In distribution | |
| 5598909 | In distribution | |
| 5597824 | In distribution | |
| 5598931 | In distribution | |
| 5598917 | In distribution | |
| 5598904 | In distribution | |
| 5598947 | In distribution | |
| 5598937 | In distribution | |
| 5597817 | In distribution | |
| 5598936 | In distribution | |
| 5597820 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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.