Proximal Humerus Plating System
Proximal Humerus Fixation System, Tray A, Metaphyseal Screw Caddy
5manufacturers in China registered for this device type
14catalogue 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 | Skeletal Dynamics L.L.C. |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| 510(k) | K102103 |
| Record published | 2025-12-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Proximal Humerus Fixation System, Tray A, Diaphyseal Screw Caddy | In distribution | |
| Proximal Humerus Fixation System, Tray A, Bottom Insert | In distribution | |
| Proximal Humerus Fixation System, Tray B, Base | In distribution | |
| Proximal Humerus Fixation System, Tray B, Bottom Insert | In distribution | |
| Proximal Humerus Fixation System, Tray A, Base | In distribution | |
| Proximal Humerus Fixation System, Tray A, Implant Caddy | In distribution | |
| Proximal Humerus Fixation System, Tray A, Metaphyseal Screw Caddy | In distribution | |
| Proximal Humerus Fixation System, Tray A, Top Insert | In distribution | |
| Proximal Humerus Fixation System, Tray B, AIMing Guide Caddy | In distribution | |
| Proximal Humerus Fixation System, Tray B, Lid | In distribution | |
| Proximal Humerus Fixation System, Tray A, Lid | In distribution | |
| Proximal Humerus Fixation System, Tray B, Top Insert | In distribution | |
| Proximal Humerus Fixation System, Tray A | In distribution | |
| Proximal Humerus Fixation System, Tray B | 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.