Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System
3.5 mm x 44 mm CC Smooth Translating Screw
11manufacturers in China registered for this device type
697catalogue numbers in this listing
2recalls on this code
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 | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2025-12-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-524536E | In distribution | |
| 14-524132E | In distribution | |
| 14-524144E | In distribution | |
| 14-524830 | Device Size Text, specify—LINEUM MEDIUM OCCIPITAL PLATE | In distribution |
| 14-524009E | Device Size Text, specify—LINEUM 3.5MM X 80MM COCR ROD | In distribution |
| 14-524057 | Device Size Text, specify—LINEUM 60 DEG COCR OCC ROD | In distribution |
| 14-524416E | In distribution | |
| 14-524532E | In distribution | |
| 14-524512E | In distribution | |
| 14-524930 | Device Size Text, specify—3.5MM X 40MM CURVED TI ROD | In distribution |
| 14-524516E | In distribution | |
| 14-524130E | In distribution | |
| 14-524708 | Device Size Text, specify—LINEUM 4.35MM X 8MM CC SCREW | In distribution |
| 14-524029 | Device Size Text, specify—60 DEG COCR DOUBLE BEND OC ROD | In distribution |
| 14-524440E | In distribution | |
| 14-524915E | In distribution | |
| 14-524964E | In distribution | |
| 14-524136 | Device Size Text, specify—LINEUM 3.5MM X 36MM ML SCREW | In distribution |
| 14-524244E | In distribution | |
| 14-524394E | In distribution | |
| 14-524908 | Device Size Text, specify—LINEUM 5.0MM X 8MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524240E | In distribution | |
| 14-524915 | Device Size Text, specify—LINEUM 5.0MM X 15MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524059E | Device Size Text, specify—LINEUM 75 DEG COCR OCC ROD | In distribution |
| 14-524248 | Device Size Text, specify—LINEUM 3.5MM X 48MM CC SCREW | In distribution |
| 14-524018E | Device Size Text, specify—LINEUM 3.5MM X 180MM TI ROD | In distribution |
| 14-524120 | Device Size Text, specify—LINEUM 3.5MM X 20MM ML SCREW | In distribution |
| 14-524232E | In distribution | |
| 14-524742E | In distribution | |
| 14-524244 | Device Size Text, specify—LINEUM 3.5MM X 44MM CC SCREW | In distribution |
| 14-524650E | In distribution | |
| 14-524908E | In distribution | |
| 14-524936 | Device Size Text, specify—3.5MM X 70MM CURVED TI ROD | In distribution |
| 14-524825 | Device Size Text, specify—LINEUM SMALL OCCIPITAL PLATE | In distribution |
| 14-524156 | Device Size Text, specify—LINEUM 3.5MMX6MM FIXED SCREW | In distribution |
| 14-524509E | In distribution | |
| 14-524825E | In distribution | |
| 14-524406 | Device Size Text, specify—LINEUM 4.0MM X 6MM ML SCREW | In distribution |
| 14-524550E | In distribution | |
| 14-524538E | In distribution | |
| 14-524328E | In distribution | |
| 14-524407 | Device Size Text, specify—LINEUM 4.0MM X 7MM ML SCREW | In distribution |
| 14-524424 | Device Size Text, specify—LINEUM 4.0MM X 24MM ML SCREW | In distribution |
| 14-524720E | In distribution | |
| 14-524338E | In distribution | |
| 14-524963 | Device Size Text, specify—LINEUM 3.5MM X 150MM COCR ROD | In distribution |
| 14-524238E | In distribution | |
| 14-524426 | Device Size Text, specify—LINEUM 4.0MM X 26MM ML SCREW | In distribution |
| 14-524182 | Device Size Text, specify—LINEUM 3.5MMX32MM FIXED SCREW | In distribution |
| 14-524162E | In distribution | |
| 14-524947 | Device Size Text, specify—3.5MM X 120MM CURVED COCR ROD | In distribution |
| 14-525053 | In distribution | |
| 14-524532 | Device Size Text, specify—LINEUM 4.0MM X 32MM CC SCREW | In distribution |
| 14-524200 | Device Size Text, specify—LINEUM 3.5MMX50MM FIXED SCREW | In distribution |
| 14-524636E | In distribution | |
| 14-524168 | Device Size Text, specify—LINEUM 3.5MMX18MM FIXED SCREW | In distribution |
| 14-524740E | In distribution | |
| 14-524432 | Device Size Text, specify—LINEUM 4.0MM X 32MM ML SCREW | In distribution |
| 14-524107 | Device Size Text, specify—LINEUM 3.5MM X 7MM ML SCREW | In distribution |
| 14-524740 | Device Size Text, specify—LINEUM 4.35MM X 40MM CC SCREW | In distribution |
| 14-524005E | Device Size Text, specify—LINEUM 3.5MM X 40MM COCR ROD | In distribution |
| 14-524190 | Device Size Text, specify—LINEUM 3.5MMX40MM FIXED SCREW | In distribution |
| 14-524446E | In distribution | |
| 14-524939E | In distribution | |
| 14-524806 | Device Size Text, specify—LINEUM 4.5MM X 6MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524155 | Device Size Text, specify—LINEUM 3.5MMX5MM FIXED SCREW | In distribution |
| 14-524045E | Device Size Text, specify—LINEUM OCCIPITAL HF PLUG | In distribution |
| 14-524538 | Device Size Text, specify—LINEUM 4.0MM X 38MM CC SCREW | In distribution |
| 14-524818E | In distribution | |
| 14-524524 | Device Size Text, specify—LINEUM 4.0MM X 24MM CC SCREW | In distribution |
| 14-524709E | In distribution | |
| 14-524196 | Device Size Text, specify—LINEUM 3.5MMX46MM FIXED SCREW | In distribution |
| 14-524709 | Device Size Text, specify—LINEUM 4.35MM X 9MM CC SCREW | In distribution |
| 14-524136E | In distribution | |
| 1200-0027E | Device Size Text, specify—ALTIUS M-INI ROD CONNECTOR 3.5MM / 5.5MM | In distribution |
| 14-524966E | In distribution | |
| 14-524943 | Device Size Text, specify—3.5MM X 100MM CURVED COCR ROD | In distribution |
| 14-524814E | In distribution | |
| 14-524840E | In distribution | |
| 14-524438 | Device Size Text, specify—LINEUM 4.0MM X 38MM ML SCREW | In distribution |
| 14-524444E | In distribution | |
| 14-524708E | In distribution | |
| 14-525050 | Device Size Text, specify—LINEUM OCC STARTER FLEXIBLE LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524158E | In distribution | |
| 14-524640E | In distribution | |
| 14-524944 | Device Size Text, specify—3.5MM X 110MM CURVED TI ROD | In distribution |
| 14-524644E | In distribution | |
| 14-524212 | Device Size Text, specify—LINEUM 3.5MM X 12MM CC SCREW | In distribution |
| 14-524516 | Device Size Text, specify—LINEUM 4.0MM X 16MM CC SCREW | In distribution |
| 14-524436 | Device Size Text, specify—LINEUM 4.0MM X 36MM ML SCREW | In distribution |
| 14-524931 | Device Size Text, specify—3.5MM X 40MM CURVED COCR ROD | In distribution |
| 14-524422 | Device Size Text, specify—LINEUM 4.0MM X 22MM ML SCREW | In distribution |
| 14-524013E | Device Size Text, specify—LINEUM 3.5MM X 120MM COCR ROD | In distribution |
| 14-524224E | In distribution | |
| 14-524180E | In distribution | |
| 14-524336 | Device Size Text, specify—LINEUM 3.5MM X 36MM ML SMOOTH | In distribution |
| 14-524410 | Device Size Text, specify—LINEUM 4.0MM X 10MM ML SCREW | In distribution |
| 14-524512 | Device Size Text, specify—LINEUM 4.0MM X 12MM CC SCREW | In distribution |
| 14-524965 | Device Size Text, specify—LINEUM 3.5MM X 160MM COCR ROD | In distribution |
| 14-524209E | In distribution | |
| 14-524438E | In distribution | |
| 14-524112 | Device Size Text, specify—LINEUM 3.5MM X 12MM ML SCREW | In distribution |
| 14-524426E | In distribution | |
| 14-524917E | In distribution | |
| 14-524238 | Device Size Text, specify—LINEUM 3.5MM X 38MM CC SCREW | In distribution |
| 14-524159E | In distribution | |
| 1200-1223 | Device Size Text, specify—46MM – 80MM | In distribution |
| 14-524006 | Device Size Text, specify—LINEUM 3.5MM X 60MM TI ROD | In distribution |
| 14-524932 | Device Size Text, specify—3.5MM X 50MM CURVED TI ROD | In distribution |
| 14-524134 | Device Size Text, specify—LINEUM 3.5MM X 34MM ML SCREW | In distribution |
| 14-524414E | In distribution | |
| 14-524030 | Device Size Text, specify—75 DEG TI DOUBLE BEND OC ROD | In distribution |
| 1200-0027 | Device Size Text, specify—TI ROD CONNECTOR 3.5MM / 6.35MM | In distribution |
| 14-524054 | Device Size Text, specify—LINEUM 45 DEG TI OCC ROD | In distribution |
| 14-524222E | In distribution | |
| 14-524817E | In distribution | |
| 14-524130 | Device Size Text, specify—LINEUM 3.5MM X 30MM ML SCREW | In distribution |
| 14-524956 | Device Size Text, specify—LINEUM 3.5MM X 110MM TI ROD | In distribution |
| 14-524966 | Device Size Text, specify—LINEUM 3.5MM X 170MM TI ROD | In distribution |
| 14-524157 | Device Size Text, specify—LINEUM 3.5MMX7MM FIXED SCREW | In distribution |
| 14-524830E | In distribution | |
| 14-524146E | In distribution | |
| 14-524232 | Device Size Text, specify—LINEUM 3.5MM X 32MM CC SCREW | In distribution |
| 14-524906 | Device Size Text, specify—LINEUM 5.0MM X 6MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524808E | In distribution | |
| 14-524109 | Device Size Text, specify—LINEUM 3.5MM X 9MM ML SCREW | In distribution |
| 1200-0020 | Device Size Text, specify—3.5MM / 3.5MM | In distribution |
| 14-524344 | Device Size Text, specify—LINEUM 3.5MM X 44MM ML SMOOTH | In distribution |
| 14-524350E | In distribution | |
| 1200-0025E | Device Size Text, specify—ALTIUS M-INI ROD CONNECTOR 3.5MM / 6.35MM | In distribution |
| 14-524450E | In distribution | |
| 14-524726E | In distribution | |
| 14-524048 | Device Size Text, specify—LINEUM 3.5/6.35 TI TRAN ROD | In distribution |
| 14-524164 | Device Size Text, specify—LINEUM 3.5MMX14MM FIXED SCREW | In distribution |
| 14-524710E | In distribution | |
| 14-524336E | In distribution | |
| 14-524917 | Device Size Text, specify—LINEUM 5.0MM X 17MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524920 | Device Size Text, specify—LINEUM 5.0MM X 20MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524126 | Device Size Text, specify—LINEUM 3.5MM X 26MM ML SCREW | In distribution |
| 14-524176E | In distribution | |
| 14-524206E | In distribution | |
| 14-524916E | In distribution | |
| 14-524414 | Device Size Text, specify—LINEUM 4.0MM X 14MM ML SCREW | In distribution |
| 14-524420E | In distribution | |
| 14-524180 | Device Size Text, specify—LINEUM 3.5MMX30MM FIXED SCREW | In distribution |
| 14-524630 | Device Size Text, specify—LINEUM 4.35MM X 30MM ML SCREW | In distribution |
| 14-524160E | In distribution | |
| 14-524718E | In distribution | |
| 14-524726 | Device Size Text, specify—LINEUM 4.35MM X 26MM CC SCREW | In distribution |
| 14-524918E | In distribution | |
| 14-524390E | In distribution | |
| 14-524422E | In distribution | |
| 14-524510 | Device Size Text, specify—LINEUM 4.0MM X 10MM CC SCREW | In distribution |
| 14-524164E | In distribution | |
| 14-524616 | Device Size Text, specify—LINEUM 4.35MM X 16MM ML SCREW | In distribution |
| 14-524448E | In distribution | |
| 14-524132 | Device Size Text, specify—LINEUM 3.5MM X 32MM ML SCREW | In distribution |
| 14-524216E | In distribution | |
| 14-524246E | In distribution | |
| 14-524018 | Device Size Text, specify—LINEUM 3.5MM X 180MM TI ROD | In distribution |
| 14-524037E | Device Size Text, specify—LINEUM 6.0MM THROAT RH HOOK | In distribution |
| 14-524156E | In distribution | |
| 1200-1221 | Device Size Text, specify—25MM – 38MM | In distribution |
| 14-524124E | In distribution | |
| 14-525008 | Device Size Text, specify—LINEUM 3.5MM TAP LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524058 | Device Size Text, specify—LINEUM 75 DEG TI OCC ROD | In distribution |
| 14-524407E | In distribution | |
| 14-524182E | In distribution | |
| 14-524326E | In distribution | |
| 14-524348 | Device Size Text, specify—LINEUM 3.5MM X 48MM ML SMOOTH | In distribution |
| 14-524206 | Device Size Text, specify—LINEUM 3.5MM X 6MM CC SCREW | In distribution |
| 14-524019 | Device Size Text, specify—LINEUM 3.5MM X 180MM COCR ROD | In distribution |
| 14-524208E | In distribution | |
| 14-524714 | Device Size Text, specify—LINEUM 4.35MM X 14MM CC SCREW | In distribution |
| 14-524432E | In distribution | |
| 14-524518 | Device Size Text, specify—LINEUM 4.0MM X 18MM CC SCREW | In distribution |
| 14-524706E | In distribution | |
| 14-524372E | In distribution | |
| 14-524450 | Device Size Text, specify—LINEUM 4.0MM X 50MM ML SCREW | In distribution |
| 14-524394 | Device Size Text, specify—LINEUM 3.5MM X 44MM CC SMOOTH | In distribution |
| 14-524194 | Device Size Text, specify—LINEUM 3.5MMX44MM FIXED SCREW | In distribution |
| 14-524410E | In distribution | |
| 14-524236 | Device Size Text, specify—LINEUM 3.5MM X 36MM CC SCREW | In distribution |
| 14-524914 | Device Size Text, specify—LINEUM 5.0MM X 14MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524646 | Device Size Text, specify—LINEUM 4.35MM X 46MM ML SCREW | In distribution |
| 14-524958 | Device Size Text, specify—LINEUM 3.5MM X 130MM TI ROD | In distribution |
| 14-524714E | In distribution | |
| 14-524106E | Device Size Text, specify—3.5 mm x 6 mm ML Screw Translating Screw | In distribution |
| 14-524750 | Device Size Text, specify—LINEUM 4.35MM X 50MM CC SCREW | In distribution |
| 14-524114 | Device Size Text, specify—LINEUM 3.5MM X 14MM ML SCREW | In distribution |
| 14-524612E | In distribution | |
| 14-524011E | Device Size Text, specify—LINEUM 3.5MM X 100MM COCR ROD | In distribution |
| 14-524742 | Device Size Text, specify—LINEUM 4.35MM X 42MM CC SCREW | In distribution |
| 14-524606E | In distribution | |
| 14-524937 | Device Size Text, specify—3.5MM X 70MM CURVED COCR ROD | In distribution |
| 14-524005 | Device Size Text, specify—LINEUM 3.5MM X 40MM COCR ROD | In distribution |
| 14-524188E | In distribution | |
| 14-524618 | Device Size Text, specify—LINEUM 4.35MM X 18MM ML SCREW | In distribution |
| 14-524110 | Device Size Text, specify—LINEUM 3.5MM X 10MM ML SCREW | In distribution |
| 14-524370 | Device Size Text, specify—LINEUM 3.5MM X 20MM CC SMOOTH | In distribution |
| 14-524194E | In distribution | |
| 14-524748E | In distribution | |
| 14-524939 | Device Size Text, specify—3.5MM X 80MM CURVED COCR ROD | In distribution |
| 14-524610E | In distribution | |
| 1200-1223E | Device Size Text, specify—ARCHED CROSS CONNECTOR 46MM – 80MM | In distribution |
| 14-524910E | In distribution | |
| 14-524207 | Device Size Text, specify—LINEUM 3.5MM X 7MM CC SCREW | In distribution |
| 14-524544E | In distribution | |
| 14-524520E | In distribution | |
| 14-524134E | In distribution | |
| 14-524946E | In distribution | |
| 14-524938 | Device Size Text, specify—3.5MM X 80MM CURVED TI ROD | In distribution |
| 14-524380E | In distribution | |
| 14-524024 | Device Size Text, specify—LINEUM 3.5MM X 240MM TI ROD | In distribution |
| 14-524046E | Device Size Text, specify—LINEUM 3.5/5.5 TI TRAN ROD | In distribution |
| 14-524388 | Device Size Text, specify—LINEUM 3.5MM X 38MM CC SMOOTH | In distribution |
| 14-524030E | Device Size Text, specify—75 DEG TI DOUBLE BEND OC ROD | In distribution |
| 14-524813 | Device Size Text, specify—LINEUM 4.5MM X 13MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524648E | In distribution | |
| 14-524959E | In distribution | |
| 14-524750E | In distribution | |
| 14-525037 | Device Size Text, specify—LINEUM HF PLUG DRIVER LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524946 | Device Size Text, specify—3.5MM X 120MM CURVED TI ROD | In distribution |
| 14-524509 | Device Size Text, specify—LINEUM 4.0MM X 9MM CC SCREW | In distribution |
| 14-524514 | Device Size Text, specify—LINEUM 4.0MM X 14MM CC SCREW | In distribution |
| 14-524378E | In distribution | |
| 14-524035E | Device Size Text, specify—LINEUM 4.5MM THROAT RH HOOK | In distribution |
| 14-524546E | In distribution | |
| 14-524546 | Device Size Text, specify—LINEUM 4.0MM X 46MM CC SCREW | In distribution |
| 14-524332E | In distribution | |
| 14-524190E | In distribution | |
| 14-524346 | Device Size Text, specify—LINEUM 3.5MM X 46MM ML SMOOTH | In distribution |
| 14-524954E | In distribution | |
| 14-524906E | In distribution | |
| 14-524933E | In distribution | |
| 14-525024 | Device Size Text, specify—LINEUM REDUCER WITH HANDLE LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524707E | In distribution | |
| 14-524812 | Device Size Text, specify—LINEUM 4.5MM X 12MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524819E | In distribution | |
| 14-524528 | Device Size Text, specify—LINEUM 4.0MM X 28MM CC SCREW | In distribution |
| 14-524534E | In distribution | |
| 14-524033 | Device Size Text, specify—90 DEG COCR DOUBLE BEND OC ROD | In distribution |
| 14-524178E | In distribution | |
| 14-524334 | Device Size Text, specify—LINEUM 3.5MM X 34MM ML SMOOTH | In distribution |
| 14-524945E | In distribution | |
| 14-524022E | Device Size Text, specify—3.5 mm X 220 mm Ti Rod | In distribution |
| 14-524146 | Device Size Text, specify—LINEUM 3.5MM X 46MM ML SCREW | In distribution |
| 1200-1220E | Device Size Text, specify—ARCHED CROSS CONNECTOR 20MM – 26MM | In distribution |
| 14-524390 | Device Size Text, specify—LINEUM 3.5MM X 40MM CC SMOOTH | In distribution |
| 14-524039 | Device Size Text, specify—LINEUM STD. LATERAL CONNECTOR | In distribution |
Showing 250 of 300 catalogue numbers.
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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-07-30 | Class II | Nonconforming Material/Component | The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications | 16,429 devices (Thoracolumbosacral pedicle screw system,Spin | 2021-04-28 |
| 2015-07-22 | Class II | Device Design | Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities. | 49 | 2015-12-10 |
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.