PolyLock SmallBone
TailorsLock 2.0 Distal Drill
3manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Fusion Orthopedics, LLC, United States |
|---|---|
| FDA product code | LXI |
| Device type | Guide, Drill, Ligament |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Record published | 2023-06-12 |
| Record revised | 2024-08-02 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CD-TB-1918 | In distribution | |
| CD-TB-1919 | 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.