CrossRoads Modular Tray System
The CrossRoads Modular Tray System organizes and protects reusable CrossRoads instruments during transport, steam sterilization and storage. Multiple pieces assemble into a case with…
The CrossRoads Modular Tray System organizes and protects reusable CrossRoads instruments during transport, steam sterilization and storage. Multiple pieces assemble into a case with lift-out organizing trays; all components are perforated for steam penetration.
The family includes lids, empty trays and internal instrument trays. The filed staple-instrument inner tray is one organizing component within the larger assembly. The system is used with sterilization wrap during the pre-vacuum steam process to maintain the sterile barrier.
Listed Item
Crossroads Inner Tray – Staple Inst
Construction and Load
The lid and base are aluminum, with stainless steel latches. Inserts use silicone, aluminum, stainless steel and nylon coating; lift-out trays can also use PROPYLUX and Radel polymers. The maximum validated load is 18.7 pounds for the tray and instruments together.
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 | Crossroads Extremity Systems LLC, United States |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K241050 |
| Record published | 2024-08-01 |
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 |
|---|---|---|
| CROSSROADS INNER TRAY – STAPLE INST | In distribution | |
| CROSSROADS TRAY – LAPIDUS/MIDFOOT | In distribution | |
| CROSSROADS INNER TRAY – PLATE INST. | In distribution | |
| CROSSROADS TRAY OUTER CASE | In distribution | |
| CROSSROADS KEEL-LOCK CADDY | In distribution | |
| CROSSROADS 1/3 LID | In distribution | |
| CROSSROADS INNER TRAY – MTP | In distribution | |
| CROSSROADS 2/3 LID | In distribution | |
| CROSSROADS EMPTY 1/3 TRAY | In distribution | |
| OUTER LID CROSSROADS TRAY – NEW | In distribution | |
| CROSSROADS EMPTY 2/3 TRAY | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241050 | 2024-07-16 |
| K202268 | 2020-12-30 |
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.