Surfix
Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone…
Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
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 | Newdeal Sas, 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 |
| 510(k) | K063820 |
| Record published | 2017-10-09 |
| Record revised | 2024-02-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Store in dry place. |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 286320ND | 3.5mm diam. x 20mm length | In distribution |
| 186200ND | 2.7mm diam. | In distribution |
| 286328ND | 3.5mm diam. x 28mm length | In distribution |
| 286220ND | 2.7mm diam. x 20mm length | In distribution |
| 286326ND | 3.5mm diam. x 26mm length | In distribution |
| 286224ND | 2.7mm diam. x 24mm length | In distribution |
| 286212ND | 2.7mm diam. x 12mm length | In distribution |
| 186300ND | 3.5mm diam. | In distribution |
| 286322ND | 3.5mm diam. x 22mm length | In distribution |
| 286318ND | 3.5mm diam. x 18mm length | 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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2012-02-09 | Class II | Labeling design | Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery. | 2,437 units | 2013-02-19 |
| Integra Lifesciences Corporation | 510(k) number | 2010-11-18 | Not classified | Other | Integra LifeSciences Corporation has decided to initiate a voluntary recall of the Uni-Comp Kits due to inaccurate information relative to the recommended sterilization parameters described in the products Instructions for Use (IFU). The s | Sixty seven (67) Kits | 2011-11-18 |
| Integra Lifesciences Corporation | 510(k) number | 2008-09-30 | Not classified | Nonconforming Material/Component | Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate | 90 | 2009-05-11 |
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.