Lineum® OCT
130 catalogue numbers from 14-524155E, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
130catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2021-09-25 |
| 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 |
|---|---|---|
| 14-524155E | 3.5 mm x 5 mm Fixed Screw | In distribution |
| 14-524638E | 4.35 mm x 38 mm ML Screw Translating Screw | In distribution |
| 14-524518E | 4.0 mm x 18 mm CC Screw Translating Screw | In distribution |
| 14-524158E | 3.5 mm x 8 mm Fixed Screw | In distribution |
| 14-524322E | 3.5 mm x 22 mm ML Smooth Translating Screw | In distribution |
| 14-524009E | 3.5 mm x 80 mm CoCr Rod | In distribution |
| 14-524606E | 4.35 mm x 6 mm ML Screw Translating Screw | In distribution |
| 14-524712E | 4.35 mm x 12 mm CC Screw Translating Screw | In distribution |
| 14-524039E | Std. Lateral Connector | In distribution |
| 14-524961E | 3.5 mm x 140 mm CoCr Rod | In distribution |
| 1200-1220E | Arched Cross Connector | In distribution |
| 14-525228E | 6.5 x 28 mm Cross-Connector Head to Head Cross-Connector | In distribution |
| 14-524530E | 4.0 mm x 30 mm CC Screw Translating Screw | In distribution |
| 14-524605E | 4.35 mm x 5 mm ML Screw Translating Screw | In distribution |
| 14-524036E | 6.0 mm Throat Lh Hook | In distribution |
| 14-524146E | 3.5 mm x 46 mm ML Screw Translating Screw | In distribution |
| 14-524825E | Small Occipital Plate | In distribution |
| 14-524428E | 4.0 mm x 28 mm ML Screw Translating Screw | In distribution |
| 14-524234E | 3.5 mm x 34 mm CC Screw Translating Screw | In distribution |
| 14-524011E | 3.5 mm x 100 mm CoCr Rod | In distribution |
| 14-524240E | 3.5 mm x 40 mm CC Screw Translating Screw | In distribution |
| 14-524007E | 3.5 mm x 60 mm CoCr Rod | In distribution |
| 14-524915E | 5.0 mm x 15 mm Occ Screw | In distribution |
| 14-524033E | 90° CoCr Double Bend Oc Rod | In distribution |
| 14-524917E | 5.0 mm x 17 mm Occ Screw | In distribution |
| 14-524058E | 75° Ti Occ Rod | In distribution |
| 14-525242E | 8.0 x 42 mm Cross-Connector Head to Head Cross-Connector | In distribution |
| 14-524955E | 3.5 mm x 90 mm CoCr Rod | In distribution |
| 1200-0027E | Rod Connector | In distribution |
| 14-524640E | 4.35 mm x 40 mm ML Screw Translating Screw | In distribution |
| 14-524936E | 3.5 mm x 70 mm Curved Ti Rod | In distribution |
| 14-524055E | 45° CoCr Occ Rod | In distribution |
| 14-525128E | 4.5 x 28 mm Cross-Connector Head to Head Cross-Connector | In distribution |
| 14-524184E | 3.5 mm x 34 mm Fixed Screw | In distribution |
| 1200-1221E | Arched Cross Connector | In distribution |
| 14-524405E | 4.0 mm x 5 mm ML Screw Translating Screw | In distribution |
| 14-524018E | 3.5 mm x 180 mm Ti Rod | In distribution |
| 1200-1222E | Arched Cross Connector | In distribution |
| 14-524710E | 4.35 mm x 10 mm CC Screw Translating Screw | In distribution |
| 14-524159E | 3.5 mm x 9 mm Fixed Screw | In distribution |
| 14-524919E | 5.0 mm X 19 mm Occ Screw | In distribution |
| 14-524507E | 4.0 mm x 7 mm CC Screw Translating Screw | In distribution |
| 14-524634E | 4.35 mm x 34 mm ML Screw Translating Screw | In distribution |
| 14-524350E | 3.5 mm x 50 mm ML Smooth Translating Screw | In distribution |
| 14-524205E | 3.5 mm x 5 mm CC Screw Translating Screw | In distribution |
| 1200-0021E | Rod Connector | In distribution |
| 14-524907E | 5.0 mm x 7 mm Occ Screw | In distribution |
| 14-524748E | 4.35 mm x 48 mm CC Screw Translating Screw | In distribution |
| 14-524944E | 3.5 mm x 110 mm Curved Ti Rod | In distribution |
| 14-524409E | 4.0 mm x 9 mm ML Screw Translating Screw | In distribution |
| 14-524436E | 4.0 mm x 36 mm ML Screw Translating Screw | In distribution |
| 14-524406E | 4.0 mm x 6 mm ML Screw Translating Screw | In distribution |
| 14-524965E | 3.5 mm x 160 mm CoCr Rod | In distribution |
| 14-524344E | 3.5 mm x 44 mm ML Smooth Translating Screw | In distribution |
| 14-524933E | 3.5 mm x 50 mm Curved CoCr Rod | In distribution |
| 14-524809E | 4.5 mm x 9 mm Occ Screw | In distribution |
| 14-524160E | 3.5 mm x 10 mm Fixed Screw | In distribution |
| 14-524618E | 4.35 mm x 18 mm ML Screw Translating Screw | In distribution |
| 14-524930E | 3.5 mm x 40 mm Curved Ti Rod | In distribution |
| 14-524392E | 3.5 mm x 42 mm CC Smooth Translating Screw | In distribution |
| 14-524722E | 4.35 mm x 22 mm CC Screw Translating Screw | In distribution |
| 14-524630E | 4.35 mm x 30 mm ML Screw Translating Screw | In distribution |
| 14-524138E | 3.5 mm x 38 mm ML Screw Translating Screw | In distribution |
| 14-524130E | 3.5 mm x 30 mm ML Screw Translating Screw | In distribution |
| 14-524622E | 4.35 mm x 22 mm ML Screw Translating Screw | In distribution |
| 14-524913E | 5.0 mm x 13 mm Occ Screw | In distribution |
| 14-524400E | 3.5 mm x 50 mm CC Smooth Translating Screw | In distribution |
| 14-525142E | 6.0 x 42 mm Cross-Connector Head to Head Cross-Connector | In distribution |
| 14-524954E | 3.5 mm x 90 mm Ti Rod | In distribution |
| 14-525110E | Double Set Screw Head to Head Cross-Connector | In distribution |
| 14-524010E | 3.5 mm x 100 mm Ti Rod | In distribution |
| 14-524156E | 3.5 mm x 6 mm Fixed Screw | In distribution |
| 1200-0020E | Rod Connector | In distribution |
| 14-524416E | 4.0 mm x 16 mm ML Screw Translating Screw | In distribution |
| 14-524006E | 3.5 mm x 60 mm Ti Rod | In distribution |
| 14-524939E | 3.5 mm x 80 mm Curved CoCr Rod | In distribution |
| 14-524442E | 4.0 mm x 42 mm ML Screw Translating Screw | In distribution |
| 14-524548E | 4.0 mm x 48 mm CC Screw Translating Screw | In distribution |
| 14-524037E | 6.0 mm Throat Rh Hook | In distribution |
| 14-524162E | 3.5 mm x 12 mm Fixed Screw | In distribution |
| 14-524608E | 4.35 mm x 8 mm ML Screw Translating Screw | In distribution |
| 14-524718E | 4.35 mm x 18 mm CC Screw Translating Screw | In distribution |
| 14-524914E | 5.0 mm x 14 mm Occ Screw | In distribution |
| 14-524815E | 4.5 mm x 15 mm Occ Screw | In distribution |
| 14-524150E | 3.5 mm x 50 mm ML Screw Translating Screw | In distribution |
| 14-524024E | 3.5 mm x 240 mm Ti Rod | In distribution |
| 14-524526E | 4.0 mm x 26 mm CC Screw Translating Screw | In distribution |
| 14-524835E | Large Occipital Plate | In distribution |
| 14-524164E | 3.5 mm x 14 mm Fixed Screw | In distribution |
| 14-524008E | 3.5 mm x 80 mm Ti Rod | In distribution |
| 14-524906E | 5.0 mm x 6 mm Occ Screw | In distribution |
| 14-524407E | 4.0 mm x 7 mm ML Screw Translating Screw | In distribution |
| 14-524628E | 4.35 mm x 28 mm ML Screw Translating Screw | In distribution |
| 1200-0025E | Rod Connector | In distribution |
| 14-524918E | 5.0 mm x 18 mm Occ Screw | In distribution |
| 14-524716E | 4.35 mm x 16 mm CC Screw Translating Screw | In distribution |
| 14-524186E | 3.5 mm x 36 mm Fixed Screw | In distribution |
| 14-524047E | 3.5/5.5 CoCr Tran Rod | In distribution |
| 14-524448E | 4.0 mm x 48 mm ML Screw Translating Screw | In distribution |
| 14-524005E | 3.5 mm x 40 mm CoCr Rod | In distribution |
| 14-525149E | 6.0 x 49 mm Cross-Connector Head to Head Cross-Connector | In distribution |
| 14-524544E | 4.0 mm x 44 mm CC Screw Translating Screw | In distribution |
| 14-524422E | 4.0 mm x 22 mm ML Screw Translating Screw | In distribution |
| 14-524817E | 4.5 mm x 17 mm Occ Screw | In distribution |
| 14-524107E | 3.5 mm x 7 mm ML Screw Translating Screw | In distribution |
| 14-524388E | 3.5 mm x 38 mm CC Smooth Translating Screw | In distribution |
| 14-524840E | X-Large Occipital Plate | In distribution |
| 14-524246E | 3.5 mm x 46 mm CC Screw Translating Screw | In distribution |
| 14-524380E | 3.5 mm x 30 mm CC Smooth Translating Screw | In distribution |
| 14-524208E | 3.5 mm x 8 mm CC Screw Translating Screw | In distribution |
| 14-524967E | 3.5 mm x 170 mm CoCr Rod | In distribution |
| 14-524346E | 3.5 mm x 46 mm ML Smooth Translating Screw | In distribution |
| 14-524942E | 3.5 mm x 100 mm Curved Ti Rod | In distribution |
| 14-524508E | 4.0 mm x 8 mm CC Screw Translating Screw | In distribution |
| 14-524916E | 5.0 mm x 16 mm Occ Screw | In distribution |
| 14-524340E | 3.5 mm x 40 mm ML Smooth Translating Screw | In distribution |
| 14-524220E | 3.5 mm x 20 mm CC Screw Translating Screw | In distribution |
| 14-524509E | 4.0 mm x 9 mm CC Screw Translating Screw | In distribution |
| 14-524206E | 3.5 mm x 6 mm CC Screw Translating Screw | In distribution |
| 14-524059E | 75° CoCr Occ Rod | In distribution |
| 14-524506E | 4.0 mm x 6 mm CC Screw Translating Screw | In distribution |
| 14-524732E | 4.35 mm x 32 mm CC Screw Translating Screw | In distribution |
| 1200-1223E | Arched Cross Connector | In distribution |
| 14-524408E | 4.0 mm x 8 mm ML Screw Translating Screw | In distribution |
| 14-524950E | 3.5 mm x 50 mm Ti Rod | In distribution |
| 14-524705E | 4.35 mm x 5 mm CC Screw Translating Screw | In distribution |
| 14-524962E | 3.5 mm x 150 mm Ti Rod | In distribution |
| 14-524172E | 3.5 mm x 22 mm Fixed Screw | In distribution |
| 14-524812E | 4.5 mm x 12 mm Occ Screw | In distribution |
| 14-524910E | 5.0 mm x 10 mm Occ Screw | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
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.