Lineum® OCT
94 catalogue numbers from 14-524108E, listed by Biomet Spine, United States, under Orthosis, Spondylolisthesis Spinal Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
94catalogue 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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2021-09-25 |
| Record revised | 2025-07-02 (version 7) |
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 |
|---|---|---|
| 14-524108E | 3.5 mm x 8 mm ML Screw Translating Screw | In distribution |
| 14-524522E | 4.0 mm x 22 mm CC Screw Translating Screw | In distribution |
| 14-524020E | 3.5 mm x 200 mm Ti Rod | In distribution |
| 14-524207E | 3.5 mm x 7 mm CC Screw Translating Screw | In distribution |
| 14-524714E | 4.35 mm x 14 mm CC Screw Translating Screw | In distribution |
| 14-524960E | 3.5 mm x 140 mm Ti Rod | In distribution |
| 14-524336E | 3.5 mm x 36 mm ML Smooth Translating Screw | In distribution |
| 14-524931E | 3.5 mm x 40 mm Curved CoCr Rod | In distribution |
| 14-524027E | 45° CoCr Double Bend Oc Rod | In distribution |
| 14-524947E | 3.5 mm x 120 mm Curved CoCr Rod | In distribution |
| 14-524909E | 5.0 mm x 9 mm Occ Screw | In distribution |
| 14-524912E | 5.0 mm x 12 mm Occ Screw | In distribution |
| 14-524196E | 3.5 mm x 46 mm Fixed Screw | In distribution |
| 14-524963E | 3.5 mm x 150 mm CoCr Rod | In distribution |
| 14-524546E | 4.0 mm x 46 mm CC Screw Translating Screw | In distribution |
| 14-524182E | 3.5 mm x 32 mm Fixed Screw | In distribution |
| 14-524708E | 4.35 mm x 8 mm CC Screw Translating Screw | In distribution |
| 14-524446E | 4.0 mm x 46 mm ML Screw Translating Screw | In distribution |
| 14-524811E | 4.5 mm x 11 mm Occ Screw | In distribution |
| 14-524614E | 4.35 mm x 14 mm ML Screw Translating Screw | In distribution |
| 14-524935E | 3.5 mm x 60 mm Curved CoCr Rod | In distribution |
| 14-524025E | 3.5 mm x 240 mm CoCr Rod | In distribution |
| 14-524166E | 3.5 mm x 16 mm Fixed Screw | In distribution |
| 14-524610E | 4.35 mm x 10 mm ML Screw Translating Screw | In distribution |
| 14-524738E | 4.35 mm x 38 mm CC Screw Translating Screw | In distribution |
| 14-524945E | 3.5 mm x 110 mm Curved CoCr Rod | In distribution |
| 14-524142E | 3.5 mm x 42 mm ML Screw Translating Screw | In distribution |
| 14-524966E | 3.5 mm x 170 mm Ti Rod | In distribution |
| 14-524940E | 3.5 mm x 90 mm Curved Ti Rod | In distribution |
| 14-524030E | 75° Ti Double Bend Oc Rod | In distribution |
| 14-524434E | 4.0 mm x 34 mm ML Screw Translating Screw | In distribution |
| 14-524720E | 4.35 mm x 20 mm CC Screw Translating Screw | In distribution |
| 14-524534E | 4.0 mm x 34 mm CC Screw Translating Screw | In distribution |
| 14-524726E | 4.35 mm x 26 mm CC Screw Translating Screw | In distribution |
| 14-524514E | 4.0 mm x 14 mm CC Screw Translating Screw | In distribution |
| 14-524330E | 3.5 mm x 30 mm ML Smooth Translating Screw | In distribution |
| 14-524021E | 3.5 mm x 200 mm CoCr Rod | In distribution |
| 14-524450E | 4.0 mm x 50 mm ML Screw Translating Screw | In distribution |
| 14-524019E | 3.5 mm x 180 mm CoCr Rod | In distribution |
| 14-524806E | 4.5 mm x 6 mm Occ Screw | In distribution |
| 14-524320E | 3.5 mm x 20 mm ML Smooth Translating Screw | In distribution |
| 14-524038E | HF Plug | In distribution |
| 14-524512E | 4.0 mm x 12 mm CC Screw Translating Screw | In distribution |
| 14-524338E | 3.5 mm x 38 mm ML Smooth Translating Screw | In distribution |
| 14-524056E | 60° Ti Occ Rod | In distribution |
| 14-524394E | 3.5 mm x 44 mm CC Smooth Translating Screw | In distribution |
| 14-524414E | 4.0 mm x 14 mm ML Screw Translating Screw | In distribution |
| 14-524440E | 4.0 mm x 40 mm ML Screw Translating Screw | In distribution |
| 14-524642E | 4.35 mm x 42 mm ML Screw Translating Screw | In distribution |
| 14-524612E | 4.35 mm x 12 mm ML Screw Translating Screw | In distribution |
| 14-524112E | 3.5 mm x 12 mm ML Screw Translating Screw | In distribution |
| 14-524398E | 3.5 mm x 48 mm CC Smooth Translating Screw | In distribution |
| 14-524644E | 4.35 mm x 44 mm ML Screw Translating Screw | In distribution |
| 14-524957E | 3.5 mm x 110 mm CoCr Rod | In distribution |
| 14-524140E | 3.5 mm x 40 mm ML Screw Translating Screw | In distribution |
| 14-524532E | 4.0 mm x 32 mm CC Screw Translating Screw | In distribution |
| 14-524106E | 3.5 mm x 6 mm ML Screw Translating Screw | In distribution |
| 14-524105E | 3.5 mm x 5 mm ML Screw Translating Screw | In distribution |
| 14-524230E | 3.5 mm x 30 mm CC Screw Translating Screw | In distribution |
| 14-524946E | 3.5 mm x 120 mm Curved Ti Rod | In distribution |
| 14-524238E | 3.5 mm x 38 mm CC Screw Translating Screw | In distribution |
| 14-524959E | 3.5 mm x 130 mm CoCr Rod | In distribution |
| 14-524180E | 3.5 mm x 30 mm Fixed Screw | In distribution |
| 14-524707E | 4.35 mm x 7 mm CC Screw Translating Screw | In distribution |
| 14-524028E | 60° Ti Double Bend Oc Rod | In distribution |
| 14-524807E | 4.5 mm x 7 mm Occ Screw | In distribution |
| 14-524136E | 3.5 mm x 36 mm ML Screw Translating Screw | In distribution |
| 14-524061E | 90° CoCr Occ Rod | In distribution |
| 14-524053E | Long Lateral Connector | In distribution |
| 14-524432E | 4.0 mm x 32 mm ML Screw Translating Screw | In distribution |
| 14-524242E | 3.5 mm x 42 mm CC Screw Translating Screw | In distribution |
| 14-524126E | 3.5 mm x 26 mm ML Screw Translating Screw | In distribution |
| 14-524332E | 3.5 mm x 32 mm ML Smooth Translating Screw | In distribution |
| 14-524178E | 3.5 mm x 28 mm Fixed Screw | In distribution |
| 14-524542E | 4.0 mm x 42 mm CC Screw Translating Screw | In distribution |
| 14-524958E | 3.5 mm x 130 mm Ti Rod | In distribution |
| 14-524013E | 3.5 mm x 120 mm CoCr Rod | In distribution |
| 14-524816E | 4.5 mm x 16 mm Occ Screw | In distribution |
| 14-524200E | 3.5 mm x 50 mm Fixed Screw | In distribution |
| 14-524626E | 4.35 mm x 26 mm ML Screw Translating Screw | In distribution |
| 14-524250E | 3.5 mm x 50 mm CC Screw Translating Screw | In distribution |
| 14-524941E | 3.5 mm x 90 mm Curved CoCr Rod | In distribution |
| 14-524032E | 90° Ti Double Bend Oc Rod | In distribution |
| 14-524045E | Occipital HF Plug | In distribution |
| 14-524326E | 3.5 mm x 26 mm ML Smooth Translating Screw | In distribution |
| 14-524540E | 4.0 mm x 40 mm CC Screw Translating Screw | In distribution |
| 14-524396E | 3.5 mm x 46 mm CC Smooth Translating Screw | In distribution |
| 14-524192E | 3.5 mm x 42 mm Fixed Screw | In distribution |
| 14-524034E | 4.5 mm Throat Lh Hook | In distribution |
| 14-524224E | 3.5 mm x 24 mm CC Screw Translating Screw | In distribution |
| 14-524328E | 3.5 mm x 28 mm ML Smooth Translating Screw | In distribution |
| 14-524124E | 3.5 mm x 24 mm ML Screw Translating Screw | In distribution |
| 14-524174E | 3.5 mm x 24 mm Fixed Screw | In distribution |
| 14-524324E | 3.5 mm x 24 mm ML Smooth Translating Screw | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal 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.