Quick – Radius Disposable Set
Quick - Radius Disposable Set - Small Plate Right and Screws
22manufacturers in China registered for this device type
33catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | GM DOS Reis Industria E Comercio Ltda, Brazil |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2024-01-26 |
| Record revised | 2025-12-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Quick – Radius Disposable Set – Large Plate Left | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| Volar FLP Versalock Plate Small Right | In distribution | |
| Quick – Radius Disposable Set – Small Plate Right and Screws | In distribution | |
| Quick – Radius Disposable Set – Large Plate Right and Screws | In distribution | |
| Mini Versa Screw Torxdrive Ti T7 | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| FLP Small and Large Template Left / Right – Single Use | In distribution | |
| Quick – Radius Disposable Set – Small Plate Left | In distribution | |
| Quick – Radius Disposable Set – Small Plate Left and Screws | In distribution | |
| Mini Versa Screw Torxdrive Ti T7 | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| Quick – Radius Disposable Set – Instruments | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| Quick – Radius Disposable Set – Small Plate Right | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| Quick – Radius Disposable Set – Remove | In distribution | |
| Volar FLP Versalock Plate Large Right | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| Mini Versa Screw Torxdrive Ti T7 | In distribution | |
| Mini Versa Screw Torxdrive Ti T7 | In distribution | |
| Quick – Radius Disposable Set – Large Plate Right | In distribution | |
| Volar FLP Versalock Plate Large Left | In distribution | |
| Volar FLP Versalock Plate Small Left | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| Mini Versa Screw Torxdrive Ti T7 | In distribution | |
| Mini Versa Screw Torxdrive Ti T7 | In distribution | |
| Quick – Radius Disposable Set – Large Plate Left and Screws | In distribution | |
| Versalock Screw Ti T7 | In distribution | |
| Versalock Screw Ti T7 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262537 | 2026-08-19 |
| K261406 | 2026-07-21 |
| K260390 | 2026-03-17 |
| K243740 | 2025-01-29 |
| K242998 | 2024-11-21 |
| K242596 | 2024-11-21 |
| K232829 | 2024-06-26 |
| K231684 | 2024-01-12 |
| K201728 | 2021-03-08 |
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.