Quantum
Complete Tray Quantum Reusable Guide
105manufacturers in China registered for this device type
20catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument
Record
| Listed by | In2Bones SAS, France |
|---|---|
| FDA product code | FSM |
| Device type | Tray, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K191380 |
| Record published | 2024-12-13 |
| Record revised | 2025-12-15 (version 8) |
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 |
|---|---|---|
| M05 10123 | In distribution | |
| M05 10211 | In distribution | |
| M05 10012 | In distribution | |
| M05 10223 | In distribution | |
| M05 10014 | In distribution | |
| M05 10122 | In distribution | |
| M05 10212 | In distribution | |
| M05 10023 | In distribution | |
| M05 10112 | In distribution | |
| M05 10022 | In distribution | |
| M05 10011 | In distribution | |
| M05 10021 | In distribution | |
| M05 10025 | In distribution | |
| M05 10222 | In distribution | |
| M05 10113 | In distribution | |
| M05 10024 | In distribution | |
| M05 10221 | In distribution | |
| M05 10013 | In distribution | |
| M05 10015 | In distribution | |
| M05 10213 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IMS | HU-Friedy MFG Co., LLC | 2,710 |
| Tray, Surgical, Instrument | Synthes Gmbh | 1,052 |
| Tray, Surgical, Instrument | Medtronic Sofamor Danek, Inc. | 1,012 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 666 |
| Aptus | Medartis Inc. | 588 |
| Acumed | Acumed LLC | 566 |
| Aesculap | Aesculap AG | 532 |
| Sklar | Sklar Corporation | 465 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 438 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 429 |
| Level ONE | KLS-Martin L.P. | 341 |
| Bahadir USA | Bahadir USA LLC | 300 |
Showing 12 of 3,212. All products under Tray, Surgical, Instrument
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.