Super Upper Limbs Versalock Plating System
VERSALOCK 2,0mm REINFORCED QUINCUNX "T" MINI PLATE (2/4), 6 HOLES
31manufacturers in China registered for this device type
20catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | GM DOS Reis Industria E Comercio Ltda, Brazil |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2024-01-26 |
| Record revised | 2026-04-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MICRO TRAPEZOIDAL VERSA PLATE RIGHT 1.5mm 8H | In distribution | |
| MINI Y RECTANGULAR VERSA PLATE 2.0mm 8H | In distribution | |
| MICRO RECTANGULAR VERSA PLATE 1.5mm 10H | In distribution | |
| MINI VERSA SCREW TORXDRIVE TI T6 Ø2,3×6,0mm | In distribution | |
| MICRO RECTANGULAR VERSA PLATE 1.5mm 4H | In distribution | |
| MINI TRAPEZOIDAL VERSA PLATE LEFT 2.0mm 8H | In distribution | |
| MINI TRAPEZOIDAL VERSA PLATE RIGHT 2.0mm 8H | In distribution | |
| MICRO T QUINCUNX VERSA PLATE 1.5mm 8H | In distribution | |
| VERSALOCK SPANNING PLATE 150.0mm, ANGLED | In distribution | |
| MINI RECTANGULAR VERSA PLATE 2.0mm 4H | In distribution | |
| MINI STRAIGHT VERSA PLATE 2.0mm 16H | In distribution | |
| MICRO STRAIGHT VERSA PLATE 1.5mm 16H | In distribution | |
| VERSALOCK 2,0mm REINFORCED QUINCUNX “T” MINI PLATE (2/4), 6 HOLES | In distribution | |
| MICRO Y QUINCUNX VERSA PLATE 1.5mm 6H | In distribution | |
| MINI Y QUINCUNX VERSA PLATE 2.0mm 7H | In distribution | |
| MICRO RECTANGULAR VERSA PLATE 1.5mm 6H | In distribution | |
| MINI Y RECTANGULAR VERSA PLATE 2.0mm 12H | In distribution | |
| MINI Y RECTANGULAR VERSA PLATE 2.0mm 10H | In distribution | |
| MICRO TRAPEZOIDAL VERSA PLATE LEFT 1.5mm 8H | In distribution | |
| MINI T QUINCUNX VERSA PLATE 2.0mm 7H | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230397 | 2023-06-12 |
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.