Arthrex®
Threaded BMA Adapter
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | LXI |
| Device type | Guide, Drill, Ligament |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-10-12 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-1001-TH-PWR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PolyLock | Fusion Orthopedics, LLC | 14 |
| PolyLock Midfoot | Fusion Orthopedics, LLC | 12 |
| DynaBridge | Fusion Orthopedics, LLC | 11 |
| Kitsune | Medshape, Inc. | 6 |
| LTJ | Azurmeds, Inc. | 6 |
| LapiLock | Fusion Orthopedics, LLC | 6 |
| FuzeFix Large | Fusion Orthopedics, LLC | 6 |
| Bonecam | Medline Industries, Inc. | 3 |
| PolyLock Ankle | Fusion Orthopedics, LLC | 3 |
| Drill Tube | Sontec Instruments, Inc. | 3 |
| Drill Guide | Sontec Instruments, Inc. | 3 |
| Universal Drill Guide | Sontec Instruments, Inc. | 2 |
Showing 12 of 34. All products under Guide, Drill, Ligament
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.