Lock Screw Square Drive
40 catalogue numbers from 1318-35-126, listed by Biomet Orthopedics, United States, under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
40catalogue numbers in this listing
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 | Biomet Orthopedics, 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 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 9) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1318-35-126 | 3.5MM X 26MM | In distribution |
| 131827120 | 2.7 MM x 20 MM | In distribution |
| 131827124 | 2.7MM X 24MM | In distribution |
| 131827118 | 2.7MM X 18MM | In distribution |
| 1318-35-130 | 3.5 MM x 30 MM | In distribution |
| 1318-35-118 | 3.5MM X 18MM | In distribution |
| 1318-35-112 | 3.5 MM x 12 MM | In distribution |
| 131827120 | 2.7MM X 20MM | In distribution |
| 1318-35-122 | 3.5MM X 22MM | In distribution |
| 131827116 | 2.7MM X 16MM | In distribution |
| 131827118 | 2.7 MM x 18 MM | In distribution |
| 131827128 | 2.7MM X 28MM | In distribution |
| 131827113 | 2.7 MM x 13 MM | In distribution |
| 131827115 | 2.7 MM x 15 MM | In distribution |
| 131827124 | 2.7 MM x 24 MM | In distribution |
| 131827115 | 2.7MM X 15MM | In distribution |
| 1318-35-124 | 3.5 MM x 24 MM | In distribution |
| 131827130 | 2.7MM X 30MM | In distribution |
| 131827130 | 2.7 MM x 30 MM | In distribution |
| 131827114 | 2.7MM X 14MM | In distribution |
| 131827122 | 2.7 MM x 22 MM | In distribution |
| 131827111 | 2.7MM X 11MM | In distribution |
| 1318-35-116 | 3.5MM X 16MM | In distribution |
| 131827110 | 2.7MM X 10MM | In distribution |
| 1318-35-110 | 3.5 MM x 10 MM | In distribution |
| 131827128 | 2.7 MM x 28 MM | In distribution |
| 131827126 | 2.7 MM x 26 MM | In distribution |
| 1318-35-126 | 3.5 MM x 26 MM | In distribution |
| 131827113 | 2.7MM X 13MM | In distribution |
| 1318-35-120 | 3.5 MM x 20 MM | In distribution |
| 1318-35-122 | 3.5 MM x 22 MM | In distribution |
| 131827122 | 2.7MM X 22MM | In distribution |
| 131827112 | 2.7 MM x 12 MM | In distribution |
| 1318-35-130 | 3.5MM X 30MM | In distribution |
| 131827126 | 2.7MM X 26MM | In distribution |
| 131827112 | 2.7MM X 12MM | In distribution |
| 1318-35-118 | 3.5 MM x 18 MM | In distribution |
| 131827111 | 2.7 MM x 11 MM | In distribution |
| 131827110 | 2.7 MM x 10 MM | In distribution |
| 1318-35-108 | 3.5MM X 8MM | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020905 | 2002-04-15 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | UDI-DI | 2018-11-20 | Class II | Packaging process control | One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws | 50 pieces | 2020-04-14 |
| Biomet, Inc. | UDI-DI | 2018-11-20 | Class II | Packaging process control | One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws | 50 pieces | 2020-04-14 |
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.