Truelok System
Steri-Tray, Empty, True/LOK Plus, Hinges AND Distractors
6manufacturers in China registered for this device type
138catalogue numbers in this listing
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 | Orthofix SRL, Italy |
|---|---|
| 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 | Manufacturer, Exporter |
| 510(k) | K941048 |
| Record published | 2018-04-28 |
| Record revised | 2025-10-24 (version 9) |
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, manufacturing date, serial number |
| Sizes | Width 11 to 190 mm; length 180 to 400 mm; outer diameter 1.8 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Width 113 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 179 mm | In distribution |
| 1 | Width 101 mm | In distribution |
| 1 | Width 163 mm | In distribution |
| 1 | Width 111 mm | In distribution |
| 1 | Width 51 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Width 61 mm | In distribution |
| 1 | Width 110 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 36 mm | In distribution |
| 1 | Width 48 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 55 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 166 mm | In distribution |
| 1 | Width 68 mm | In distribution |
| 1 | Width 26 mm | In distribution |
| 1 | Width 66 mm | In distribution |
| 1 | Width 99 mm | In distribution |
| 1 | Width 60 mm | In distribution |
| 1 | Width 16 mm | In distribution |
| 1 | Width 40 mm | In distribution |
| 1 | Width 64 mm | In distribution |
| 1 | Width 104 mm | In distribution |
| 1 | Width 63 mm | In distribution |
| 1 | Width 83 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 177 mm | In distribution |
| 1 | Width 95 mm | In distribution |
| 1 | Width 28 mm | In distribution |
| 1 | Width 102 mm | In distribution |
| 1 | Width 165 mm | In distribution |
| 1 | Width 107 mm | In distribution |
| 1 | Width 90 mm | In distribution |
| 1 | Width 131 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 49 mm | In distribution |
| 1 | Width 171 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 12 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 162 mm | In distribution |
| 1 | Width 49 mm | In distribution |
| 1 | Width 11 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 53 mm | In distribution |
| 1 | Width 88 mm | In distribution |
| 1 | Width 72 mm | In distribution |
| 1 | Width 187 mm | In distribution |
| 1 | Width 182 mm | In distribution |
| 1 | Width 102 mm | In distribution |
| 1 | Width 14 mm | In distribution |
| 1 | Width 18 mm | In distribution |
| 1 | Width 22 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 136 mm | In distribution |
| 1 | Width 104 mm | In distribution |
| 1 | Width 20 mm | In distribution |
| 1 | Width 112 mm | In distribution |
| 1 | Width 97 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 173 mm | In distribution |
| 1 | Width 92 mm | In distribution |
| 1 | Width 93 mm | In distribution |
| 1 | Width 91 mm | In distribution |
| 1 | Width 62 mm | In distribution |
| 1 | Width 94 mm | In distribution |
| 1 | Width 78 mm | In distribution |
| 1 | Width 137 mm | In distribution |
| 1 | Width 72 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 70 mm | In distribution |
| 1 | Width 96 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 47 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 34 mm | In distribution |
| 1 | Width 75 mm | In distribution |
| 1 | Width 67 mm | In distribution |
| 1 | Width 134 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 132 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 180 mm | In distribution |
| 1 | Width 60 mm | In distribution |
| 1 | Width 190 mm | In distribution |
| 1 | Width 114 mm | In distribution |
| 1 | Width 133 mm | In distribution |
| 1 | Width 164 mm | In distribution |
| 1 | Width 115 mm | In distribution |
| 1 | Width 99 mm | In distribution |
| 1 | Width 24 mm | In distribution |
| 1 | Width 135 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 400 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 138 mm | In distribution |
| 1 | Width 32 mm | In distribution |
| 1 | Width 178 mm | In distribution |
| 1 | Outer Diameter 1.8 mm | In distribution |
| 1 | Width 188 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 66 mm | In distribution |
| 1 | Width 84 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 58 mm | In distribution |
| 1 | Width 82 mm | In distribution |
| 1 | Width 167 mm | In distribution |
| 1 | Width 65 mm | In distribution |
| 1 | Width 59 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 189 mm | In distribution |
| 1 | Width 43 mm | In distribution |
| 1 | Width 45 mm | In distribution |
| 1 | Width 150 mm | In distribution |
| 1 | Width 30 mm | In distribution |
| 1 | Width 64 mm | In distribution |
| 1 | Width 58 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Width 176 mm | In distribution |
| 1 | Width 62 mm | In distribution |
| 1 | Width 80 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 76 mm | In distribution |
| 1 | Width 161 mm | In distribution |
| 1 | Width 114 mm | In distribution |
| 1 | Width 47 mm | In distribution |
| 1 | Width 74 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 90 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True/LOK Monolateral/Bilateral Fixator | Orthofix SRL | 206 |
| 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 |
| Smooth Locking PEG | Biomet Orthopedics | 28 |
Showing 12 of 261. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthofix US LLC | 510(k) number | 2007-09-28 | Not classified | Process control | Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted. | 69 units. | 2008-03-20 |
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.