Polaris™ 6.35 Spinal System
215 catalogue numbers from 14-501042, 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
215catalogue 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 | 2020-06-23 |
| Record revised | 2025-07-02 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-501042 | 16MM INSIDE FIXED CROSS 6.35 | In distribution |
| 14-515865 | 6.35 TI 10.5X65MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513585R | 7.5MM X 85MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573425 | 6.5 X 25MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-515670 | 6.35 TI 8.5X70MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-501059 | 32MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-573445 | 6.5 X 45MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-515260 | 6.35 TI 4.75X60MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573570 | 7.5 X 70MM MULTIAXIAL ILIAC SCREW | In distribution |
| 14-501058 | 30MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-575518 | SMALL: WIDE LAMINAR HOOK | In distribution |
| 14-513870R | 10.5MM X 70MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-515485 | 6.35 TI 6.5X85MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573495 | 6.5 X 95MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-515490 | 6.35 TI 6.5X90MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513670R | 8.5MM X 70MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573455 | 6.5 X 55MM MULTIAXIAL ILIAC | In distribution |
| 14-513845R | 10.5MM X 45MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513220R | 4.75MM X 20MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513165R | 4.0MM X 65MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573230 | 4.75 X 30MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-575526 | MEDIUM: NARROW LAMINAR HOOK | In distribution |
| 14-513460 | 6.5MM X 60MM UNIPLANAR SCREW | In distribution |
| 14-513199 | 4.0MM X 100MM UNIPLANAR SCREW | In distribution |
| 14-573855 | 10.5 X 55MM MULTIAXIAL ILIAC | In distribution |
| 14-515575 | 6.35 TI 7.5X75MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513235 | 4.75MM X 35MM UNIPLANAR SCREW | In distribution |
| 14-574550C | 7.5MM(D) X 50MM SST CANNULATED FIXED SCREW | In distribution |
| 14-574645C | 8.5MM(D) X 45MM SST CANNULATED FIXED SCREW | In distribution |
| 5500122-07 | 6.35MM SINGLE B.E. ROD, SS ANNEALED, 7CM LENGTH | In distribution |
| 50-6550MP | MULTI-AXIAL SCREW 4.0MM (D) X 20MM (L) | In distribution |
| 14-515535 | 6.35 TI 7.5X35MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-572435 | 6.5 X 35MM MULTIAXIAL SCREW | In distribution |
| 14-573860 | 10.5 X 60MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-573260 | 4.75 X 60MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 5500120-08 | 6.35MM SINGLE B.E. ROD, CPTI 8CM LENGTH | In distribution |
| 14-574635C | 8.5MM(D) X 35MM SST CANNULATED FIXED SCREW | In distribution |
| 14-513130 | 4.0MM X 30MM UNIPLANAR SCREW | In distribution |
| 14-513165 | 4.0MM X 65MM UNIPLANAR SCREW | In distribution |
| 14-513740R | 9.5MM X 40MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-575562 | SMALL RIGHT TP HOOK 6.35 SST | In distribution |
| 14-501043 | 18MM INSIDE FIXED CROSS 6.35 | In distribution |
| 14-575562 | SMALL RIGHT TP HOOK 6.35 SST | In distribution |
| 14-501047 | 26MM INSIDE FIXED CROSS 6.35 | In distribution |
| 14-513420R | 6.5MM X 20MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-577545 | 7.5MM(D) X 45MM SST MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573335 | 5.5 X 35MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513470R | 6.5MM X 70MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513750R | 9.5MM X 50MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573565 | 7.5 X 65MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513220 | 4.75MM X 20MM UNIPLANAR SCREW | In distribution |
| 14-513520 | 7.5MM X 20MM UNIPLANAR SCREW | In distribution |
| 14-574545C | 7.5MM(D) X 45MM SST CANNULATED FIXED SCREW | In distribution |
| 14-573665 | 8.5 X 65MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513520R | 7.5MM X 20MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513580 | 7.5MM X 80MM UNIPLANAR SCREW | In distribution |
| 14-513480 | 6.5MM X 80MM UNIPLANAR SCREW | In distribution |
| 14-574650C | 8.5MM(D) X 50MM SST CANNULATED FIXED SCREW | In distribution |
| 14-573350 | 5.5 X 50MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-575516 | LARGE: RIGHT ANGLED HOOK | In distribution |
| 14-575568 | LARGE LEFT TP HOOK 6.35 SST | In distribution |
| 14-572535C | 7.5MM(D) X 35MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 14-577535 | 7.5MM(D) X 35MM SST MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513890R | 10.5MM X 90MM REDUCTION UNIPLANAR SCREW | In distribution |
| 5500120-07 | 6.35MM SINGLE B.E. ROD, CPTI 7CM LENGTH | In distribution |
| 14-573875 | 10.5 X 75MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513875R | 10.5MM X 75MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-515435 | 6.35 TI 6.5X35MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513290 | 4.75MM X 90MM UNIPLANAR SCREW | In distribution |
| 5500120-10 | 6.35MM SINGLE B.E. ROD, CPTI 10CM LENGTH | In distribution |
| 14-573795 | 9.5 X 95MM MULTIAXIAL ILIAC | In distribution |
| 14-515290 | 6.35 TI 4.75X90MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-575413 | 280MM SST MEDIUM ROD W/HEX | In distribution |
| 14-501289 | 6.5MM(D) X 55MM(L) MULTIAXIAL DOUBLE LEAD SCREW (6.35) | In distribution |
| 14-513685 | 8.5MM X 85MM UNIPLANAR SCREW | In distribution |
| 14-501056 | 26MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-574140 | 4.0MM(D) X 40MM FIXED SCREW | In distribution |
| 14-573880 | 10.5 X 80MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513820R | 10.5MM X 20MM REDUCTION UNIPLANAR SCREW | In distribution |
| 53-6805MP | TI VARIABLE LOCKING SCREW 4.75 X 30MM REDUCT. SEAT ASSY | In distribution |
| 14-513375R | 5.5MM X 75MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-515450 | 6.35 TI 6.5X50MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 53-6806MP | TI VARIABLE LOCKING SCREW 4.75 X 35MM REDUCT. SEAT ASSY | In distribution |
| 14-573395 | 5.5 X 95MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-515630 | 6.35 TI 8.5X30MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573350 | 5.5 X 50MM MULTIAXIAL ILIAC | In distribution |
| 14-515695 | 6.35 TI 8.5X95MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573495 | 6.5 X 95MM MULTIAXIAL ILIAC | In distribution |
| 14-575406 | 510MM ROD, HARD, W/HEX, SST | In distribution |
| 14-501053 | 20MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-577550 | 7.5MM(D) X 50MM SST MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573899 | 10.5 X 100MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-574350 | 5.5MM(D) X 50MM FIXED SCREW | In distribution |
| 14-513890 | 10.5MM X 90MM UNIPLANAR SCREW | In distribution |
| 14-574430C | 6.5MM(D) X 30MM SST CANNULATED FIXED SCREW | In distribution |
| 14-513425R | 6.5MM X 25MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513899 | 10.5MM X 100MM UNIPLANAR SCREW | In distribution |
| 14-515250 | 6.35 TI 4.75X50MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573790 | 9.5 X 90MM MULTIAXIAL ILIAC | In distribution |
| 14-513365 | 5.5MM X 65MM UNIPLANAR SCREW | In distribution |
| 14-574340 | 5.5MM(D) X 40MM FIXED SCREW | In distribution |
| 53-6552MP | TI VARIABLE LOCKING SCREW 4.0x30MM REDUCTION SEAT ASSY | In distribution |
| 14-572450 | 6.5 X 50MM MULTIAXIAL SCREW | In distribution |
| 14-573750 | 9.5 X 50MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 53-6807MP | REDUCTION MULTI-AXIAL SCREW 4.75MM X 40MM(L) EXTENDED | In distribution |
| 14-577440 | 6.5MM(D) X 40MM SST MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-572340 | 5.5 X 40MM MULTIAXIAL SCREW | In distribution |
| 14-515480 | 6.35 TI 6.5X80MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573330 | 5.5 X 30MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513530R | 7.5MM X 30MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513295R | 4.75MM X 95MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513540 | 7.5MM X 40MM UNIPLANAR SCREW | In distribution |
| 14-574435C | 6.5MM(D) X 35MM SST CANNULATED FIXED SCREW | In distribution |
| 14-572335 | 5.5 X 35MM MULTIAXIAL SCREW | In distribution |
| 14-574135 | 4.0MM(D) X 35MM FIXED SCREW | In distribution |
| 14-572430C | 6.5MM(D) X 30MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 14-573785 | 9.5 X 85MM MULTIAXIAL ILIAC | In distribution |
| 14-575402 | 510MM ROD, MEDIUM, W/HEX, SST | In distribution |
| 14-575404 | 510MM ROD, HARD, 6.35 SST | In distribution |
| 14-572445C | 6.5MM(D) X 45MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 14-573785 | 9.5 X 85MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 50-6553MP | MULTI-AXIAL SCREW 4.0MM (D) X 35MM (L) | In distribution |
| 14-513590R | 7.5MM X 90MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573850 | 10.5 X 50MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-515560 | 6.35 TI 7.5X60MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-515745 | 6.35 TI 9.5X45MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-572350 | 5.5 X 50MM MULTIAXIAL SCREW | In distribution |
| 14-574655C | 8.5MM(D) X 55MM SST CANNULATED FIXED SCREW | In distribution |
| 14-575524 | SMALL: NARROW LAMINAR HOOK | In distribution |
| 50-6594MP | 5.0 X 40MM HF SEAT ASSY | In distribution |
| 14-515725 | 6.35 TI 9.5X25MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513735R | 9.5MM X 35MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573845 | 10.5 X 45MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-515370 | 6.35 TI 5.5X70MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-501052 | 18MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-573670 | 8.5 X 70MM MULTIAXIAL ILIAC SCREW | In distribution |
| 14-501051 | 16MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-572545C | 7.5MM(D) X 45MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 14-501062 | 26MM OUTSIDE FIXED CROSS 6.35 | In distribution |
| 14-573735 | 9.5 X 35MM MULTIAXIAL ILIAC | In distribution |
| 14-513755 | 9.5MM X 55MM UNIPLANAR SCREW | In distribution |
| 14-573240 | 4.75 X 40MM MULTIAXIAL ILIAC | In distribution |
| 14-573199 | 4.0 X 100MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-573170 | 4.0 X 70MM MULTIAXIAL ILIAC | In distribution |
| 14-501057 | 28MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-573525 | 7.5 X 25MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-572330C | 5.5MM(D) X 30MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 14-575520 | MEDIUM: WIDE LAMINAR HOOK | In distribution |
| 14-513485 | 6.5MM X 85MM UNIPLANAR SCREW | In distribution |
| 14-513430R | 6.5MM X 30MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513730 | 9.5MM X 30MM UNIPLANAR SCREW | In distribution |
| 14-573730 | 9.5 X 30MM MULTIAXIAL ILIAC | In distribution |
| 14-513665R | 8.5MM X 65MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-575530 | SMALL: NARROW REDUCED LAMINAR HOOK | In distribution |
| 14-513835 | 10.5MM X 35MM UNIPLANAR SCREW | In distribution |
| 14-575405 | 610MM ROD, HARD, 6.35 SST | In distribution |
| 14-515599 | 6.35 TI 7.5X100MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-572350C | 5.5MM(D) X 50MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 14-501058 | 30MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-515775 | 6.35 TI 9.5X75MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-515225 | 6.35 TI 4.75X25MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-515425 | 6.35 TI 6.5X25MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-575542 | MEDIUM: RIGHT OFFSET HOOK | In distribution |
| 14-572645C | 8.5MM(D) X 45MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 14-501061 | 24MM OUTSIDE FIXED CROSS 6.35 | In distribution |
| 14-573595 | 7.5 X 95MM MULTIAXIAL ILIAC | In distribution |
| 14-573299 | 4.75 X 100MM MULTIAXIAL ILIAC | In distribution |
| 14-513825 | 10.5MM X 25MM UNIPLANAR SCREW | In distribution |
| 14-575171 | ANGULATING CROSS CONNECTOR,M | In distribution |
| 14-573465 | 6.5 X 65MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513135R | 4.0MM X 35MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573320 | 5.5 X 20MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-573499 | 6.5 X 100MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-501044 | 20MM INSIDE FIXED CROSS 6.35 | In distribution |
| 14-573895 | 10.5 X 95MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513240 | 4.75MM X 40MM UNIPLANAR SCREW | In distribution |
| 14-573890 | 10.5 X 90MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-573295 | 4.75 X 95MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-574245 | 4.75MM(D) X 45MM FIXED SCREW | In distribution |
| 14-501063 | 28MM OUTSIDE FIXED CROSS 6.35 | In distribution |
| 14-513695R | 8.5MM X 95MM REDUCTION UNIPLANAR SCREW | In distribution |
| 6585MP | VLS SCREW W/FLUTES-6.35 | In distribution |
| 50-6591MP | 5.0 X 25MM HF SEAT ASSY | In distribution |
| 14-501293 | 6.5MM(D) X 75MM(L) MULTIAXIAL | In distribution |
| 14-573130 | 4.0 X 30MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-515665 | 6.35 TI 8.5X65MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-515430 | 6.35 TI 6.5X30MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-501047 | 26MM INSIDE FIXED CROSS 6.35 | In distribution |
| 50-6552MP | 4.0MM (D) X 30MM (L) | In distribution |
| 14-515385 | 6.35 TI 5.5X85MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 50-6804MP | MULTI-AXIAL SCREW 4.75MM (D) X 25MM (L) | In distribution |
| 14-574535 | 7.5MM(D) X 35MM FIXED SCREW | In distribution |
| 14-573380 | 5.5 X 80MM MULTIAXIAL ILIAC | In distribution |
| 14-515495 | 6.35 TI 6.5X95MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513840R | 10.5MM X 40MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-575170 | ANGULATING CROSS CONNECTOR,S | In distribution |
| 14-513355R | 5.5MM X 55MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-501045 | 22MM INSIDE FIXED CROSS 6.35 | In distribution |
| 50-6805MP | 4.75MM (D) X 30MM (L) | In distribution |
| 14-513455 | 6.5MM X 55MM UNIPLANAR SCREW | In distribution |
| 14-513770R | 9.5MM X 70MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-575538 | SMALL: RIGHT OFFSET HOOK | In distribution |
| 14-515790 | 6.35 TI 9.5X90MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573620 | 8.5 X 20MM MULTIAXIAL ILIAC | In distribution |
| 14-513190R | 4.0MM X 90MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573385 | 5.5 X 85MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513340R | 5.5MM X 40MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-572130 | 4.0 X 30MM MULTIAXIAL SCREW | In distribution |
| 53-6554MP | TI VARIABLE LOCKING SCREW 4.0x40MM REDUCTION SEAT ASSY | In distribution |
| 14-513475R | 6.5MM X 75MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573250 | 4.75 X 50MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-511555 | 7.5MM X 55MM MULTI-AXIAL SCREW | In distribution |
| 53-6801MP | REDUCTION MULTI-AXIAL SCREW 7.0MM (D) X 55MM (L) EXTENDED | In distribution |
| 14-572550 | 7.5 X 50MM MULTIAXIAL SCREW | In distribution |
| 14-513285R | 4.75MM X 85MM REDUCTION UNIPLANAR 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.