TK2 ™standard Barrel
16 catalogue numbers from 8415-40-004, 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
16catalogue 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 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2021-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8415-40-004 | 140 DEG 4H | Withdrawn |
| 8315-35-014 | 135° 14 HOLE 272.9MM LENGTH | Withdrawn |
| 8315-30-004 | 130°4 HOLE 92.6MM LENGTH | Withdrawn |
| 8415-35-008 | 135 DEG 8H | Withdrawn |
| 8315-35-010 | 135° 10 HOLE 200.8MM LENGTH | Withdrawn |
| 8315-30-012 | 130° 12 HOLE 236.9MM LENGTH | Withdrawn |
| 8415-45-003 | 145 DEG 3H | Withdrawn |
| 8415-40-012 | 140 DEG 12H | Withdrawn |
| 8415-50-006 | 150 DEG 6H | Withdrawn |
| 8415-35-005 | 135 DEG 5H | Withdrawn |
| 8415-50-010 | 150 DEG 10H | Withdrawn |
| 8415-35-004 | 135 DEG 4H | Withdrawn |
| 8415-35-006 | 135 DEG 6H | Withdrawn |
| 8415-30-010 | 130 DEG 10H | Withdrawn |
| 8315-45-010 | 145° 10 HOLE 200.8MM LENGTH | Withdrawn |
| 8415-45-005 | 145 DEG 5H | Withdrawn |
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 |
|---|---|
| K020905 | 2002-04-15 |
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.