Lineum OCT Spine System
266 catalogue numbers from 14-525228E, 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
266catalogue 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 | 2016-10-07 |
| Record revised | 2025-07-02 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-525228E | 6.5X28MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524812 | LINEUM 4.5MM X 12MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524607 | LINEUM 4.35MM X 7MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-525111E | SMALL NUT ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524222 | LINEUM 3.5MM X 22MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-525156 | 6.0X56MM CROSS-CONNECTOR | In distribution |
| 14-524048E | LINEUM 3.5/6.35 TI TRAN ROD | In distribution |
| 14-525149 | 6.0X49MM CROSS-CONNECTOR | In distribution |
| 14-524965 | LINEUM 3.5MM X 160MM COCR ROD | In distribution |
| 14-524105 | LINEUM 3.5MM X 5MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524420 | LINEUM 4.0MM X 20MM ML SCREW | In distribution |
| 14-524709 | LINEUM 4.35MM X 9MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524548 | LINEUM 4.0MM X 48MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524726 | LINEUM 4.35MM X 26MM CC SCREW | In distribution |
| 14-524166 | LINEUM 3.5MMX16MM FIXED SCREW | In distribution |
| 14-524018 | LINEUM 3.5MM X 180MM TI ROD | In distribution |
| 14-524732 | LINEUM 4.35MM X 32MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-525110 | DOUBLE SET SCREW | In distribution |
| 14-524919 | LINEUM 5.0MM X 19MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524418 | LINEUM 4.0MM X 18MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524198 | LINEUM 3.5MMX48MM FIXED SCREW | In distribution |
| 14-524640 | LINEUM 4.35MM X 40MM ML SCREW | In distribution |
| 14-525223 | 6.5X23MM CROSS-CONNECTOR | In distribution |
| 14-524158 | LINEUM 3.5MMX8MM FIXED SCREW | In distribution |
| 14-524507 | LINEUM 4.0MM X 7MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524409 | LINEUM 4.0MM X 9MM ML SCREW | In distribution |
| 14-524918 | LINEUM 5.0MM X 18MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524032 | 90 DEG TI DOUBLE BEND OC ROD | In distribution |
| 14-524943 | 3.5MM X 100MM CURVED COCR ROD | In distribution |
| 14-524542 | LINEUM 4.0MM X 42MM CC SCREW | In distribution |
| 14-524609 | LINEUM 4.35MM X 9MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524328 | LINEUM 3.5MM X 28MM ML SMOOTH TRANSLATING SCREW | In distribution |
| 14-524018E | LINEUM 3.5MM X 180MM TI ROD | In distribution |
| 14-524188 | LINEUM 3.5MMX38MM FIXED SCREW | In distribution |
| 14-524061 | LINEUM 90 DEG COCR OCC ROD | In distribution |
| 14-524045 | LINEUM OCCIPITAL HF PLUG | In distribution |
| 14-524732 | LINEUM 4.35MM X 32MM CC SCREW | In distribution |
| 14-524021 | LINEUM 3.5MM X 200MM COCR ROD | In distribution |
| 14-524650 | LINEUM 4.35MM X 50MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524817E | LINEUM 4.5MM X 17MM OCC SCREW | In distribution |
| 14-524392 | LINEUM 3.5MM X 42MM CC SMOOTH | In distribution |
| 14-524212 | LINEUM 3.5MM X 12MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-525110E | DOUBLE SET SCREW ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM | In distribution |
| 14-525128E | 4.5X28MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524224 | LINEUM 3.5MM X 24MM CC SCREW | In distribution |
| 14-524946E | 3.5MM X 120MM CURVED TI ROD | In distribution |
| 14-524009 | LINEUM 3.5MM X 80MM COCR ROD | In distribution |
| 14-524648 | LINEUM 4.35MM X 48MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524380 | LINEUM 3.5MM X 30MM CC SMOOTH TRANSLATING SCREW | In distribution |
| 14-524512 | LINEUM 4.0MM X 12MM CC SCREW | In distribution |
| 14-524442 | LINEUM 4.0MM X 42MM ML SCREW | In distribution |
| 14-524035E | LINEUM 4.5MM THROAT RH HOOK | In distribution |
| 14-524208 | LINEUM 3.5MM X 8MM CC SCREW | In distribution |
| 14-524218 | LINEUM 3.5MM X 18MM CC SCREW | In distribution |
| 14-524638 | LINEUM 4.35MM X 38MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524332 | LINEUM 3.5MM X 32MM ML SMOOTH TRANSLATING SCREW | In distribution |
| 14-524722 | LINEUM 4.35MM X 22MM CC SCREW | In distribution |
| 14-524710 | LINEUM 4.35MM X 10MM CC SCREW | In distribution |
| 14-524344 | LINEUM 3.5MM X 44MM ML SMOOTH TRANSLATING SCREW | In distribution |
| 14-524106 | LINEUM 3.5MM X 6MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524053E | LINEUM LONG LATERAL CONNECTOR | In distribution |
| 14-524194 | LINEUM 3.5MMX44MM FIXED SCREW | In distribution |
| 14-525223E | 6.5X23MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524230 | LINEUM 3.5MM X 30MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524736 | LINEUM 4.35MM X 36MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524815 | LINEUM 4.5MM X 15MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524911E | LINEUM 5.0MM X 11MM OCC SCREW | In distribution |
| 14-524409 | LINEUM 4.0MM X 9MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524434 | LINEUM 4.0MM X 34MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524610 | LINEUM 4.35MM X 10MM ML SCREW | In distribution |
| 14-524045E | LINEUM OCCIPITAL HF PLUG | In distribution |
| 14-524108 | LINEUM 3.5MM X 8MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524182 | LINEUM 3.5MMX32MM FIXED SCREW | In distribution |
| 14-524718 | LINEUM 4.35MM X 18MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524730 | LINEUM 4.35MM X 30MM CC SCREW | In distribution |
| 14-524933 | 3.5MM X 50MM CURVED COCR ROD | In distribution |
| 14-524156 | LINEUM 3.5MMX6MM FIXED SCREW | In distribution |
| 14-524056 | LINEUM 60 DEG TI OCC ROD | In distribution |
| 14-524811 | LINEUM 4.5MM X 11MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524396 | LINEUM 3.5MM X 46MM CC SMOOTH TRANSLATING SCREW | In distribution |
| 14-524034 | LINEUM 4.5MM THROAT LH HOOK | In distribution |
| 14-524242 | LINEUM 3.5MM X 42MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524061E | LINEUM 90 DEG COCR OCC ROD | In distribution |
| 14-524240 | LINEUM 3.5MM X 40MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524724 | LINEUM 4.35MM X 24MM CC SCREW | In distribution |
| 14-524608 | LINEUM 4.35MM X 8MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524057 | LINEUM 60 DEG COCR OCC ROD | In distribution |
| 14-524914 | LINEUM 5.0MM X 14MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524961 | LINEUM 3.5MM X 140MM COCR ROD | In distribution |
| 14-524940E | 3.5MM X 90MM CURVED TI ROD | In distribution |
| 14-525052 | LINEUM OCC SCREW DRIVER 90 LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524234 | LINEUM 3.5MM X 34MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524914E | LINEUM 5.0MM X 14MM OCC SCREW | In distribution |
| 14-524542 | LINEUM 4.0MM X 42MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524536 | LINEUM 4.0MM X 36MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524105 | LINEUM 3.5MM X 5MM ML SCREW | In distribution |
| 14-524116 | LINEUM 3.5MM X 16MM ML SCREW | In distribution |
| 14-524198 | LINEUM 3.5MMX48MM FIXED SCREW | In distribution |
| 14-524238 | LINEUM 3.5MM X 38MM CC SCREW | In distribution |
| 14-524726 | LINEUM 4.35MM X 26MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-525249E | 8.0X49MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524720 | LINEUM 4.35MM X 20MM CC SCREW | In distribution |
| 14-524907E | LINEUM 5.0MM X 7MM OCC SCREW | In distribution |
| 14-524808 | LINEUM 4.5MM X 8MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-525028 | LINEUM DORSAL HEIGHT ADJUSTER LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524817 | LINEUM 4.5MM X 17MM OCC SCREW | In distribution |
| 14-524967 | LINEUM 3.5MM X 170MM COCR ROD | In distribution |
| 14-524952E | LINEUM 3.5MM X 70MM TI ROD | In distribution |
| 14-524953E | LINEUM 3.5MM X 70MM COCR ROD | In distribution |
| 14-524048 | LINEUM 3.5/6.35 TI TRAN ROD | In distribution |
| 14-524913E | LINEUM 5.0MM X 13MM OCC SCREW | In distribution |
| 14-524180 | LINEUM 3.5MMX30MM FIXED SCREW | In distribution |
| 14-524058 | LINEUM 75 DEG TI OCC ROD | In distribution |
| 14-524628 | LINEUM 4.35MM X 28MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-525111 | SMALL NUT | In distribution |
| 14-525054 | LINEUM OCCIPITAL HOLE COVER LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524132 | LINEUM 3.5MM X 32MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-525024 | LINEUM REDUCER WITH HANDLE LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524390 | LINEUM 3.5MM X 40MM CC SMOOTH TRANSLATING SCREW | In distribution |
| 14-524004 | LINEUM 3.5MM X 40MM TI ROD | In distribution |
| 14-524962 | LINEUM 3.5MM X 150MM TI ROD | In distribution |
| 14-524128 | LINEUM 3.5MM X 28MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524915 | LINEUM 5.0MM X 15MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524634 | LINEUM 4.35MM X 34MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524816E | LINEUM 4.5MM X 16MM OCC SCREW | In distribution |
| 14-524400 | LINEUM 3.5MM X 50MM CC SMOOTH | In distribution |
| 14-524155 | LINEUM 3.5MMX5MM FIXED SCREW | In distribution |
| 14-524945 | 3.5MM X 110MM CURVED COCR ROD | In distribution |
| 14-524508 | LINEUM 4.0MM X 8MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524246 | LINEUM 3.5MM X 46MM CC SCREW | In distribution |
| 14-524907 | LINEUM 5.0MM X 7MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524609 | LINEUM 4.35MM X 9MM ML SCREW | In distribution |
| 14-524124 | LINEUM 3.5MM X 24MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524037E | LINEUM 6.0MM THROAT RH HOOK | In distribution |
| 14-524634 | LINEUM 4.35MM X 34MM ML SCREW | In distribution |
| 14-524240 | LINEUM 3.5MM X 40MM CC SCREW | In distribution |
| 14-524396 | LINEUM 3.5MM X 46MM CC SMOOTH | In distribution |
| 14-524338 | LINEUM 3.5MM X 38MM ML SMOOTH | In distribution |
| 14-524350 | LINEUM 3.5MM X 50MM ML SMOOTH | In distribution |
| 14-524750 | LINEUM 4.35MM X 50MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524944E | 3.5MM X 110MM CURVED TI ROD | In distribution |
| 14-524509 | LINEUM 4.0MM X 9MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-525058 | LINEUM INNER SHAFT SUB ASSY LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524720 | LINEUM 4.35MM X 20MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524408 | LINEUM 4.0MM X 8MM ML SCREW | In distribution |
| 14-524440 | LINEUM 4.0MM X 40MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524910 | LINEUM 5.0MM X 10MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524046 | LINEUM 3.5/5.5 TI TRAN ROD | In distribution |
| 14-524007E | LINEUM 3.5MM X 60MM COCR ROD | In distribution |
| 14-524938E | 3.5MM X 80MM CURVED TI ROD | In distribution |
| 14-524023 | LINEUM 3.5MM X 220MM COCR ROD | In distribution |
| 14-525142E | 6.0X42MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524422 | LINEUM 4.0MM X 22MM ML SCREW | In distribution |
| 14-524608 | LINEUM 4.35MM X 8MM ML SCREW | In distribution |
| 14-525043 | LINEUM OCCIPITAL PLATE HOLDER LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524172 | LINEUM 3.5MMX22MM FIXED SCREW | In distribution |
| 14-524520 | LINEUM 4.0MM X 20MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524528 | LINEUM 4.0MM X 28MM CC SCREW | In distribution |
| 14-524033 | 90 DEG COCR DOUBLE BEND OC ROD | In distribution |
| 14-524170 | LINEUM 3.5MMX20MM FIXED SCREW | In distribution |
| 14-524348 | LINEUM 3.5MM X 48MM ML SMOOTH | In distribution |
| 14-524540 | LINEUM 4.0MM X 40MM CC SCREW | In distribution |
| 14-524057E | LINEUM 60 DEG COCR OCC ROD | In distribution |
| 14-524228 | LINEUM 3.5MM X 28MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524538 | LINEUM 4.0MM X 38MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524746 | LINEUM 4.35MM X 46MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524820E | LINEUM 4.5MM X 20MM OCC SCREW | In distribution |
| 14-524005E | LINEUM 3.5MM X 40MM COCR ROD | In distribution |
| 14-524032 | 90 DEG TI DOUBLE BEND OC ROD | In distribution |
| 14-524506 | LINEUM 4.0MM X 6MM CC SCREW TRANSLATING SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524160 | LINEUM 3.5MMX10MM FIXED SCREW | In distribution |
| 14-524807E | LINEUM 4.5MM X 7MM OCC SCREW | In distribution |
| 14-525135E | 6.0X35MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524959 | LINEUM 3.5MM X 130MM COCR ROD | In distribution |
| 14-524518 | LINEUM 4.0MM X 18MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524815 | LINEUM 4.5MM X 15MM OCC SCREW | In distribution |
| 14-525228 | 6.5X28MM CROSS-CONNECTOR | In distribution |
| 14-524026E | 45 DEG TI DOUBLE BEND OC ROD | In distribution |
| 14-525242E | 8.0X42MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524205 | LINEUM 3.5MM X 5MM CC SCREW | In distribution |
| 14-524724 | LINEUM 4.35MM X 24MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524136 | LINEUM 3.5MM X 36MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524234 | LINEUM 3.5MM X 34MM CC SCREW | In distribution |
| 14-524960E | LINEUM 3.5MM X 140MM TI ROD | In distribution |
| 14-524226 | LINEUM 3.5MM X 26MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524707 | LINEUM 4.35MM X 7MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524055 | LINEUM 45 DEG COCR OCC ROD | In distribution |
| 14-524947 | 3.5MM X 120MM CURVED COCR ROD | In distribution |
| 14-524610 | LINEUM 4.35MM X 10MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524730 | LINEUM 4.35MM X 30MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524207 | LINEUM 3.5MM X 7MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524534 | LINEUM 4.0MM X 34MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524110 | LINEUM 3.5MM X 10MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524047 | LINEUM 3.5/5.5 COCR TRAN ROD | In distribution |
| 14-524030 | 75 DEG TI DOUBLE BEND OC ROD | In distribution |
| 14-524934 | 3.5MM X 60MM CURVED TI ROD | In distribution |
| 14-524414 | LINEUM 4.0MM X 14MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-525011 | LINEUM SCREW INSERTER LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524332 | LINEUM 3.5MM X 32MM ML SMOOTH | In distribution |
| 14-524913 | LINEUM 5.0MM X 13MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-525249 | 8.0X49MM CROSS-CONNECTOR | In distribution |
| 14-524242 | LINEUM 3.5MM X 42MM CC SCREW | In distribution |
| 14-524376 | LINEUM 3.5MM X 26MM CC SMOOTH | In distribution |
| 14-524620 | LINEUM 4.35MM X 20MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524144 | LINEUM 3.5MM X 44MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524718 | LINEUM 4.35MM X 18MM CC SCREW | In distribution |
| 14-524122 | LINEUM 3.5MM X 22MM ML SCREW | In distribution |
| 14-524186 | LINEUM 3.5MMX36MM FIXED SCREW | In distribution |
| 14-524324 | LINEUM 3.5MM X 24MM ML SMOOTH | In distribution |
| 14-524346 | LINEUM 3.5MM X 46MM ML SMOOTH TRANSLATING SCREW | In distribution |
| 14-524605 | LINEUM 4.35MM X 5MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-524951E | LINEUM 3.5MM X 50MM COCR ROD | In distribution |
| 14-524806 | LINEUM 4.5MM X 6MM OCC SCREW | In distribution |
| 14-525046 | LINEUM OCC DRILL/TAP GUIDE LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524157 | LINEUM 3.5MMX7MM FIXED SCREW | In distribution |
| 14-524005 | LINEUM 3.5MM X 40MM COCR ROD | In distribution |
| 14-524372 | LINEUM 3.5MM X 22MM CC SMOOTH TRANSLATING SCREW | In distribution |
| 14-524418 | LINEUM 4.0MM X 18MM ML SCREW | In distribution |
| 14-524807 | LINEUM 4.5MM X 7MM OCC SCREW | In distribution |
| 14-524184 | LINEUM 3.5MMX34MM FIXED SCREW | In distribution |
| 14-524961E | LINEUM 3.5MM X 140MM COCR ROD | In distribution |
| 14-524006 | LINEUM 3.5MM X 60MM TI ROD | In distribution |
| 14-524330 | LINEUM 3.5MM X 30MM ML SMOOTH | In distribution |
| 14-524380 | LINEUM 3.5MM X 30MM CC SMOOTH | In distribution |
| 14-524384 | LINEUM 3.5MM X 34MM CC SMOOTH | In distribution |
| 14-524324 | LINEUM 3.5MM X 24MM ML SMOOTH TRANSLATING SCREW | In distribution |
| 14-524053 | LINEUM LONG LATERAL CONNECTOR | In distribution |
| 14-524036E | LINEUM 6.0MM THROAT LH HOOK | In distribution |
| 14-524224 | LINEUM 3.5MM X 24MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524334 | LINEUM 3.5MM X 34MM ML SMOOTH TRANSLATING SCREW | In distribution |
| 14-524035 | LINEUM 4.5MM THROAT RH HOOK | In distribution |
| 14-524196 | LINEUM 3.5MMX46MM FIXED SCREW | In distribution |
| 14-524810E | LINEUM 4.5MM X 10MM OCC SCREW | In distribution |
| 14-524140 | LINEUM 3.5MM X 40MM ML SCREW TRANSLATING SCREW | In distribution |
| 14-525235 | 8.0X35MM CROSS-CONNECTOR | In distribution |
| 14-524186 | LINEUM 3.5MMX36MM FIXED SCREW | In distribution |
| 14-524958 | LINEUM 3.5MM X 130MM TI ROD | In distribution |
| 14-524060 | LINEUM 90 DEG TI OCC ROD | In distribution |
| 14-524450 | LINEUM 4.0MM X 50MM ML SCREW | In distribution |
| 14-525242 | 8.0X42MM CROSS-CONNECTOR | In distribution |
| 14-524011 | LINEUM 3.5MM X 100MM COCR ROD | In distribution |
| 14-524740 | LINEUM 4.35MM X 40MM CC SCREW TRANSLATING SCREW | In distribution |
| 14-524110 | LINEUM 3.5MM X 10MM ML SCREW | In distribution |
| 14-524813 | LINEUM 4.5MM X 13MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524028 | 60 DEG TI DOUBLE BEND OC ROD | In distribution |
| 14-524326 | LINEUM 3.5MM X 26MM ML SMOOTH TRANSLATING SCREW | In distribution |
| 14-524320 | LINEUM 3.5MM X 20MM ML SMOOTH TRANSLATING SCREW | In distribution |
| 14-525010 | LINEUM 4.35MM TAP LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524814 | LINEUM 4.5MM X 14MM OCC SCREW LINEUM OCT SPINE SYSTEM | In distribution |
| 14-524059E | LINEUM 75 DEG COCR OCC ROD | In distribution |
Showing 250 of 266 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
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.