Para CPX
PARA Cross Pin External Fixation Frame and One Tightening Tool
6manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Record
| Listed by | A.M. Surgical, Inc., United States |
|---|---|
| FDA product code | LXT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K042458 |
| Record published | 2021-01-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8800-10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True/LOK Monolateral/Bilateral Fixator | Orthofix SRL | 206 |
| Truelok System | Orthofix SRL | 138 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Synthes Gmbh | 60 |
| TrueLok Evo | Orthofix SRL | 60 |
| IJS | Skeletal Dynamics L.L.C. | 48 |
| Arbor | Globus Medical, Inc. | 46 |
| Multi-Directional Screw | Biomet Orthopedics | 44 |
| LCP | Synthes Gmbh | 40 |
| Lock Screw Square Drive | Biomet Orthopedics | 40 |
| Smooth PEG | Biomet Orthopedics | 33 |
| A.l.p.s.® | Biomet Orthopedics | 32 |
| Cannulated Cancellous LAG Screw | Biomet Orthopedics | 31 |
Showing 12 of 261. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K042458 | 2004-10-07 |
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.