Lineum® OCT
119 catalogue numbers from 14-524818E, listed by Biomet Spine, United States, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
119catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2020-06-25 |
| Record revised | 2025-07-02 (version 8) |
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 |
|---|---|---|
| 14-524818E | 4.5 mm x 18 mm Occ Screw | In distribution |
| 14-524029E | 60° CoCr Double Bend Oc Rod | In distribution |
| 14-524636E | 4.35 mm x 36 mm ML Screw Translating Screw | In distribution |
| 14-524023E | 3.5 mm x 220 mm CoCr Rod | In distribution |
| 14-524616E | 4.35 mm x 16 mm ML Screw Translating Screw | In distribution |
| 14-524244E | 3.5 mm x 44 mm CC Screw Translating Screw | In distribution |
| 14-524214E | 3.5 mm x 14 mm CC Screw Translating Screw | In distribution |
| 14-524157E | 3.5 mm x 7 mm Fixed Screw | In distribution |
| 14-524212E | 3.5 mm x 12 mm CC Screw Translating Screw | In distribution |
| 14-524736E | 4.35 mm x 36 mm CC Screw Translating Screw | In distribution |
| 14-524911E | 5.0 mm x 11 mm Occ Screw | In distribution |
| 14-524128E | 3.5 mm x 28 mm ML Screw Translating Screw | In distribution |
| 14-524938E | 3.5 mm x 80 mm Curved Ti Rod | In distribution |
| 14-524386E | 3.5 mm x 36 mm CC Smooth Translating Screw | In distribution |
| 14-524742E | 4.35 mm x 42 mm CC Screw Translating Screw | In distribution |
| 14-524953E | 3.5 mm x 70 mm CoCr Rod | In distribution |
| 14-524022E | 3.5 mm X 220 mm Ti Rod | In distribution |
| 14-524232E | 3.5 mm x 32 mm CC Screw Translating Screw | In distribution |
| 14-524372E | 3.5 mm x 22 mm CC Smooth Translating Screw | In distribution |
| 14-524378E | 3.5 mm x 28 mm CC Smooth Translating Screw | In distribution |
| 14-524348E | 3.5 mm x 48 mm ML Smooth Translating Screw | In distribution |
| 14-524412E | 4.0 mm x 12 mm ML Screw Translating Screw | In distribution |
| 14-524607E | 4.35 mm x 7 mm ML Screw Translating Screw | In distribution |
| 14-524813E | 4.5 mm x 13 mm Occ Screw | In distribution |
| 14-524048E | 3.5/6.35 Ti Tran Rod | In distribution |
| 14-524730E | 4.35 mm x 30 mm CC Screw Translating Screw | In distribution |
| 14-524374E | 3.5 mm x 24 mm CC Smooth Translating Screw | In distribution |
| 14-524908E | 5.0 mm x 8 mm Occ Screw | In distribution |
| 14-524122E | 3.5 mm x 22 mm ML Screw Translating Screw | In distribution |
| 14-524426E | 4.0 mm x 26 mm ML Screw Translating Screw | In distribution |
| 14-524144E | 3.5 mm x 44 mm ML Screw Translating Screw | In distribution |
| 14-524031E | 75° CoCr Double Bend Oc Rod | In distribution |
| 14-524334E | 3.5 mm x 34 mm ML Smooth Translating Screw | In distribution |
| 14-524210E | 3.5 mm x 10 mm CC Screw Translating Screw | In distribution |
| 14-524520E | 4.0 mm x 20 mm CC Screw Translating Screw | In distribution |
| 14-524964E | 3.5 mm x 160 mm Ti Rod | In distribution |
| 14-524116E | 3.5 mm x 16 mm ML Screw Translating Screw | In distribution |
| 14-524012E | 3.5 mm x 120 mm Ti Rod | In distribution |
| 14-524620E | 4.35 mm x 20 mm ML Screw Translating Screw | In distribution |
| 14-524170E | 3.5 mm x 20 mm Fixed Screw | In distribution |
| 14-524168E | 3.5 mm x 18 mm Fixed Screw | In distribution |
| 14-524734E | 4.35 mm x 34 mm CC Screw Translating Screw | In distribution |
| 14-524709E | 4.35 mm x 9 mm CC Screw Translating Screw | In distribution |
| 14-524920E | 5.0 mm x 20 mm Occ Screw | In distribution |
| 14-524054E | 45° Ti Occ Rod | In distribution |
| 14-524216E | 3.5 mm x 16 mm CC Screw Translating Screw | In distribution |
| 14-524418E | 4.0 mm x 18 mm ML Screw Translating Screw | In distribution |
| 14-524728E | 4.35 mm x 28 mm CC Screw Translating Screw | In distribution |
| 14-524176E | 3.5 mm x 26 mm Fixed Screw | In distribution |
| 14-524209E | 3.5 mm x 9 mm CC Screw Translating Screw | In distribution |
| 14-524724E | 4.35 mm x 24 mm CC Screw Translating Screw | In distribution |
| 14-524060E | 90° Ti Occ Rod | In distribution |
| 14-524370E | 3.5 mm x 20 mm CC Smooth Translating Screw | In distribution |
| 14-524424E | 4.0 mm x 24 mm ML Screw Translating Screw | In distribution |
| 14-524057E | 60° CoCr Occ Rod | In distribution |
| 14-524120E | 3.5 mm x 20 mm ML Screw Translating Screw | In distribution |
| 14-524444E | 4.0 mm x 44 mm ML Screw Translating Screw | In distribution |
| 14-524226E | 3.5 mm x 26 mm CC Screw Translating Screw | In distribution |
| 14-524236E | 3.5 mm x 36 mm CC Screw Translating Screw | In distribution |
| 14-524810E | 4.5 mm x 10 mm Occ Screw | In distribution |
| 14-524110E | 3.5 mm x 10 mm ML Screw Translating Screw | In distribution |
| 14-524951E | 3.5 mm x 50 mm CoCr Rod | In distribution |
| 14-524384E | 3.5 mm x 34 mm CC Smooth Translating Screw | In distribution |
| 14-524819E | 4.5 mm x 19 mm Occ Screw | In distribution |
| 14-524648E | 4.35 mm x 48 mm ML Screw Translating Screw | In distribution |
| 14-524830E | Medium Occipital Plate | In distribution |
| 14-524524E | 4.0 mm x 24 mm CC Screw Translating Screw | In distribution |
| 14-524952E | 3.5 mm x 70 mm Ti Rod | In distribution |
| 14-524132E | 3.5 mm x 32 mm ML Screw Translating Screw | In distribution |
| 14-524248E | 3.5 mm x 48 mm CC Screw Translating Screw | In distribution |
| 14-524430E | 4.0 mm x 30 mm ML Screw Translating Screw | In distribution |
| 14-524382E | 3.5 mm x 32 mm CC Smooth Translating Screw | In distribution |
| 14-524046E | 3.5/5.5 Ti Tran Rod | In distribution |
| 14-524004E | 3.5 mm x 40 mm Ti Rod | In distribution |
| 14-524222E | 3.5 mm x 22 mm CC Screw Translating Screw | In distribution |
| 14-524190E | 3.5 mm x 40 mm Fixed Screw | In distribution |
| 14-524118E | 3.5 mm x 18 mm ML Screw Translating Screw | In distribution |
| 14-524646E | 4.35 mm x 46 mm ML Screw Translating Screw | In distribution |
| 14-524194E | 3.5 mm x 44 mm Fixed Screw | In distribution |
| 14-524505E | 4.0 mm x 5 mm CC Screw Translating Screw | In distribution |
| 14-524550E | 4.0 mm x 50 mm CC Screw Translating Screw | In distribution |
| 14-524114E | 3.5 mm x 14 mm ML Screw Translating Screw | In distribution |
| 14-524820E | 4.5 mm x 20 mm Occ Screw | In distribution |
| 14-524516E | 4.0 mm x 16 mm CC Screw Translating Screw | In distribution |
| 14-524538E | 4.0 mm x 38 mm CC Screw Translating Screw | In distribution |
| 14-524536E | 4.0 mm x 36 mm CC Screw Translating Screw | In distribution |
| 14-524746E | 4.35 mm x 46 mm CC Screw Translating Screw | In distribution |
| 14-524956E | 3.5 mm x 90 mm Ti Rod | In distribution |
| 14-524035E | 4.5 mm Throat Rh Hook | In distribution |
| 14-524609E | 4.35 mm x 9 mm ML Screw Translating Screw | In distribution |
| 14-524134E | 3.5 mm x 34 mm ML Screw Translating Screw | In distribution |
| 14-524808E | 4.5 mm x 8 mm Occ Screw | In distribution |
| 14-524376E | 3.5 mm x 26 mm CC Smooth Translating Screw | In distribution |
| 14-524932E | 3.5 mm x 50 mm Curved Ti Rod | In distribution |
| 14-524706E | 4.35 mm x 6 mm CC Screw Translating Screw | In distribution |
| 14-524148E | 3.5 mm x 48 mm ML Screw Translating Screw | In distribution |
| 14-524943E | 3.5 mm x 100 mm Curved CoCr Rod | In distribution |
| 14-524109E | 3.5 mm x 9 mm ML Screw Translating Screw | In distribution |
| 14-524937E | 3.5 mm x 70 mm Curved CoCr Rod | In distribution |
| 14-524510E | 4.0 mm x 10 mm CC Screw Translating Screw | In distribution |
| 14-524740E | 4.35 mm x 40 mm CC Screw Translating Screw | In distribution |
| 14-524188E | 3.5 mm x 38 mm Fixed Screw | In distribution |
| 14-524624E | 4.35 mm x 24 mm ML Screw Translating Screw | In distribution |
| 14-524218E | 3.5 mm x 18 mm CC Screw Translating Screw | In distribution |
| 14-524750E | 4.35 mm x 50 mm CC Screw Translating Screw | In distribution |
| 14-524228E | 3.5 mm x 28 mm CC Screw Translating Screw | In distribution |
| 14-524528E | 4.0 mm x 28 mm CC Screw Translating Screw | In distribution |
| 14-524934E | 3.5 mm x 60 mm Curved Ti Rod | In distribution |
| 14-524420E | 4.0 mm x 20 mm ML Screw Translating Screw | In distribution |
| 14-524650E | 4.35 mm x 50 mm ML Screw Translating Screw | In distribution |
| 14-524026E | 45° Ti Double Bend Oc Rod | In distribution |
| 14-524198E | 3.5 mm x 48 mm Fixed Screw | In distribution |
| 14-524814E | 4.5 mm x 14 mm Occ Screw | In distribution |
| 14-524390E | 3.5 mm x 40 mm CC Smooth Translating Screw | In distribution |
| 14-524410E | 4.0 mm x 10 mm ML Screw Translating Screw | In distribution |
| 14-524744E | 4.35 mm x 44 mm CC Screw Translating Screw | In distribution |
| 14-524438E | 4.0 mm x 38 mm ML Screw Translating Screw | In distribution |
| 14-524632E | 4.35 mm x 32 mm ML Screw Translating Screw | In distribution |
| 14-524342E | 3.5 mm x 42 mm ML Smooth Translating Screw | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
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.