Polaris 4.75 TI Spinal System
203 catalogue numbers from 14-583461, 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
203catalogue 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 | 2015-10-24 |
| Record revised | 2025-07-02 (version 6) |
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 |
|---|---|---|
| 14-583461 | 4.75 TI 6.0X145MM CLOSED MAS | In distribution |
| 14-583756 | 4.75 TI 7.5X140MM CLOSED MAS | In distribution |
| 14-583944 | 4.75 TI 10.5X125MM CLOSED MAS | In distribution |
| 14-581440 | 4.75 TI 4MM LAMINAR HOOK | In distribution |
| 14-589717 | 4.75 TI OFFSET CONNECTOR, 75MM | In distribution |
| 14-582440 | 4.75 TI 6.0X40MM MAS | In distribution |
| 14-583536 | 4.75 TI 6.5X120MM CLOSED MAS | In distribution |
| 14-583330 | 4.75 TI 5.5X30MM CLOSED MAS | In distribution |
| 14-582675 | 4.75 TI 7.0X75MM MAS | In distribution |
| 14-588545T | 4.75/5.5X450MM TI ALLOY ROD | In distribution |
| 14-583465 | 4.75 TI 6.0X65MM CLOSED MAS | In distribution |
| 14-589825 | 4.75 TI 25MM BRIDGE CONN | In distribution |
| 14-583551 | 4.75 TI 6.5X135MM CLOSED MAS | In distribution |
| 14-584595 | 4.75 TI 6.5X95MM FIXED SCREW | In distribution |
| 14-582690 | 4.75 TI 7.0X90MM MAS | In distribution |
| 14-584790 | 4.75 TI 7.5X90MM FIXED SCREW | In distribution |
| 14-583427 | 4.75 TI 6.0X27.5MM CLOSED MAS | In distribution |
| 14-583122 | 4.75 TI 4.5X22.5MM CLOSED MAS | In distribution |
| 14-584322 | 4.75 TI 5.5X22.5MM FIXED SCREW | In distribution |
| 14-586460CS | 4.5/4.75X600MM COCR STD ROD | In distribution |
| 14-584928 | 4.75 TI 10.5X27.5MM FIXD SCREW | In distribution |
| 14-584961 | 4.75 TI 10.5X60MM FIXED SCREW | In distribution |
| 14-587113CH | 4.75X130MM COCR HIGH HEX ROD | In distribution |
| 14-588530T | 4.75/5.5X300MM TI ALLOY ROD | In distribution |
| 14-586420CL | 4.5/4.75X200MM COCR LOW ROD | In distribution |
| 14-584980 | 4.75 TI 9.5X80MM FIXED SCREW | In distribution |
| 14-582295 | 4.75 TI 5.0X95MM MAS | In distribution |
| 14-584146 | 4.75 TI 4.5X130MM FIXED SCREW | In distribution |
| 14-587113T | 4.75X130MM TI ALLOY HEX ROD | In distribution |
| 14-583986 | 4.75 TI 10.5X85MM CLOSED MAS | In distribution |
| 14-582335 | 4.75 TI 5.5X35MM MAS | In distribution |
| 14-582350 | 4.75 TI 5.5X50MM MAS | In distribution |
| 14-583036 | 4.75 TI 4.0X120MM CLOSED MAS | In distribution |
| 14-584145 | 4.75 TI 4.5X45MM FIXED SCREW | In distribution |
| 14-584536 | 4.75 TI 6.5X120MM FIXED SCREW | In distribution |
| 14-582957 | 4.75 TI 9.5X140MM MAS | In distribution |
| 14-583625 | 4.75 TI 7.0X25MM CLOSED MAS | In distribution |
| 14-589705R | 4.75 TI RIGHT OFFSET CONN, XL | In distribution |
| 14-584527 | 4.75 TI 6.5X27.5MM FIXED SCREW | In distribution |
| 14-583981 | 4.75 TI 10.5X80MM CLOSED MAS | In distribution |
| 14-582958 | 4.75 TI 10.5X140MM MAS | In distribution |
| 14-585113T | 4.5X130MM TI ALLOY HEX ROD | In distribution |
| 14-583970 | 4.75 TI 9.5X70MM CLOSED MAS | In distribution |
| 14-589518 | 4.75 TI 18MM FIXED CROSS CONN | In distribution |
| 14-581045 | 4.75 TI MEDIUM MIDSTEM HOOK | In distribution |
| 14-583275 | 4.75 TI 5.0X75MM CLOSED MAS | In distribution |
| 14-587245T | 4.75X450MM TI ALLOY MR CRV ROD | In distribution |
| 14-584480 | 4.75 TI 6.0X80MM FIXED SCREW | In distribution |
| 14-581640L | 4.75 TI 4MM LEFT OFFSET HOOK | In distribution |
| 14-585313CL | 4.5X130MM COCR LOW LS CRV ROD | In distribution |
| 14-583955 | 4.75 TI 9.5X55MM CLOSED MAS | In distribution |
| 14-585313CS | 4.5X130MM COCR STD LS CRV ROD | In distribution |
| 14-584860 | 4.75 TI 8.5X60MM FIXED SCREW | In distribution |
| 14-582245 | 4.75 TI 5.0X45MM MAS | In distribution |
| 14-584461 | 4.75 TI 6.0X145MM FIXED SCREW | In distribution |
| 14-583964 | 4.75 TI 10.5X145MM CLOSED MAS | In distribution |
| 14-583426 | 4.75 TI 6.0X110MM CLOSED MAS | In distribution |
| 14-583961 | 4.75 TI 10.5X60MM CLOSED MAS | In distribution |
| 14-582520 | 4.75 TI 6.5X20MM MAS | In distribution |
| 14-583922 | 4.75 TI 9.5X22.5MM CLOSED MAS | In distribution |
| 14-581790 | 4.75 TI 9MM ANG BLADE HOOK | In distribution |
| 14-587330T | 4.75X300MM TI ALLOY LS CRV ROD | In distribution |
| 14-581460 | 4.75 TI LARGE LAMINAR HOOK | In distribution |
| 14-587151CL | 4.75X510MM COCR LOW HEX ROD | In distribution |
| 14-583941 | 4.75 TI 10.5X40MM CLOSED MAS | In distribution |
| 14-588530CS | 4.75/5.5X300MM COCR STD ROD | In distribution |
| 14-582431 | 4.75 TI 6.0X115MM MAS | In distribution |
| 14-583765 | 4.75 TI 7.5X65MM CLOSED MAS | In distribution |
| 14-582036 | 4.75 TI 4.0X120MM MAS | In distribution |
| 14-589725 | 4.75 TI 25MM LAT CONN | In distribution |
| 14-584365 | 4.75 TI 5.5X65MM FIXED SCREW | In distribution |
| 14-584141 | 4.75 TI 4.5X125MM FIXED SCREW | In distribution |
| 14-589111 | 4.75 TI 115MM STRGT AXIAL CONN | In distribution |
| 14-586560T | 4.5/5.5X600MM TI ALLOY ROD | In distribution |
| 14-584840 | 4.75 TI 8.5X40MM FIXED SCREW | In distribution |
| 14-581890 | 4.75 TI 9MM EXTENDED HOOK | In distribution |
| 14-586520T | 4.5/5.5X200MM TI ALLOY ROD | In distribution |
| 14-583480 | 4.75 TI 6.0X80MM CLOSED MAS | In distribution |
| 14-582923 | 4.75 TI 10.5X22.5MM MAS | In distribution |
| 14-587251CH | 4.75X510MM COCR HI MR CRV ROD | In distribution |
| 14-583425 | 4.75 TI 6.0X25MM CLOSED MAS | In distribution |
| 14-583770 | 4.75 TI 7.5X70MM CLOSED MAS | In distribution |
| 14-582085 | 4.75 TI 4.0X85MM MAS | In distribution |
| 14-585160CS | 4.5X600MM COCR STD HEX ROD | In distribution |
| 14-585213T | 4.5X130MM TI ALLOY MR CRV ROD | In distribution |
| 14-582941 | 4.75 TI 10.5X40MM MAS | In distribution |
| 14-582220 | 4.75 TI 5.0X20MM MAS | In distribution |
| 14-582320 | 4.75 TI 5.5X20MM MAS | In distribution |
| 14-587260CH | 4.75X600MM COCR HI MR CRV ROD | In distribution |
| 14-589703R | 4.75 TI RIGHT OFFSET CONN, M | In distribution |
| 14-582020 | 4.75 TI 4.0X20MM MAS | In distribution |
| 14-585245CL | 4.5X450MM COCR LOW MR CRV ROD | In distribution |
| 14-583355 | 4.75 TI 5.5X55MM CLOSED MAS | In distribution |
| 14-589510 | 4.75 TI 10MM FIXED CROSS CONN | In distribution |
| 14-584526 | 4.75 TI 6.5X110MM FIXED SCREW | In distribution |
| 14-584963 | 4.75 TI 9.5X145MM FIXED SCREW | In distribution |
| 14-584456 | 4.75 TI 6.0X140MM FIXED SCREW | In distribution |
| 14-587245CL | 4.75X450MM COCR LOW MR CRV ROD | In distribution |
| 14-581730 | 4.75 TI SMALL ANG BLADE HOOK | In distribution |
| 14-583727 | 4.75 TI 7.5X27.5MM CLOSED MAS | In distribution |
| 14-582145 | 4.75 TI 4.5X45MM MAS | In distribution |
| 14-584935 | 4.75 TI 9.5X35MM FIXED SCREW | In distribution |
| 14-582360 | 4.75 TI 5.5X60MM MAS | In distribution |
| 14-582266 | 4.75 TI 5.0X150MM MAS | In distribution |
| 14-585345CH | 4.5X450MM COCR HI LS CRV ROD | In distribution |
| 14-588560T | 4.75/5.5X600MM TI ALLOY ROD | In distribution |
| 14-586460CL | 4.5/4.75X600MM COCR LOW ROD | In distribution |
| 14-584750 | 4.75 TI 7.5X50MM FIXED SCREW | In distribution |
| 14-583322 | 4.75 TI 5.5X22.5MM CLOSED MAS | In distribution |
| 14-580906 | 4.75 TI 6MM UNIVERSAL HOOK | In distribution |
| 14-583641 | 4.75 TI 7.0X125MM CLOSED MAS | In distribution |
| 14-582456 | 4.75 TI 6.0X140MM MAS | In distribution |
| 14-583880 | 4.75 TI 8.5X80MM CLOSED MAS | In distribution |
| 14-583761 | 4.75 TI 7.5X145MM CLOSED MAS | In distribution |
| 14-588545CL | 4.75/5.5X450MM COCR LOW ROD | In distribution |
| 14-583255 | 4.75 TI 5.0X55MM CLOSED MAS | In distribution |
| 14-583975 | 4.75 TI 9.5X75MM CLOSED MAS | In distribution |
| 14-586551CL | 4.5/5.5X510MM COCR LOW ROD | In distribution |
| 14-584399 | 4.75 TI 5.5X100MM FIXED SCREW | In distribution |
| 14-582825 | 4.75 TI 8.5X25MM MAS | In distribution |
| 14-582845 | 4.75 TI 8.5X45MM MAS | In distribution |
| 14-584431 | 4.75 TI 6.0X115MM FIXED SCREW | In distribution |
| 14-584190 | 4.75 TI 4.5X90MM FIXED SCREW | In distribution |
| 14-586445CH | 4.5/4.75X450MM COCR HIGH ROD | In distribution |
| 14-584799 | 4.75 TI 7.5X100MM FIXED SCREW | In distribution |
| 14-583895 | 4.75 TI 8.5X95MM CLOSED MAS | In distribution |
| 14-582870 | 4.75 TI 8.5X70MM MAS | In distribution |
| 14-584236 | 4.75 TI 5.0X120MM FIXED SCREW | In distribution |
| 14-583967 | 4.75 TI 9.5X150MM CLOSED MAS | In distribution |
| 14-582830 | 4.75 TI 8.5X30MM MAS | In distribution |
| 14-584295 | 4.75 TI 5.0X95MM FIXED SCREW | In distribution |
| 14-583885 | 4.75 TI 8.5X85MM CLOSED MAS | In distribution |
| 14-584680 | 4.75 TI 7.0X80MM FIXED SCREW | In distribution |
| 14-582922 | 4.75 TI 9.5X22.5MM MAS | In distribution |
| 14-584825 | 4.75 TI 8.5X25MM FIXED SCREW | In distribution |
| 14-582699 | 4.75 TI 7.0X100MM MAS | In distribution |
| 14-582680 | 4.75 TI 7.0X80MM MAS | In distribution |
| 14-582160 | 4.75 TI 4.5X60MM MAS | In distribution |
| 14-584875 | 4.75 TI 8.5X75MM FIXED SCREW | In distribution |
| 14-584970 | 4.75 TI 9.5X70MM FIXED SCREW | In distribution |
| 14-584727 | 4.75 TI 7.5X27.5MM FIXED SCREW | In distribution |
| 14-583845 | 4.75 TI 8.5X45MM CLOSED MAS | In distribution |
| 14-581840 | 4.75 TI 4MM EXTENDED HOOK | In distribution |
| 14-581275R | 4.75 TI 7.5MM RT ANGLED HOOK | In distribution |
| 14-583327 | 4.75 TI 5.5X27.5MM CLOSED MAS | In distribution |
| 14-584944 | 4.75 TI 10.5X125MM FIXED SCREW | In distribution |
| 14-582851 | 4.75 TI 8.5X135MM MAS | In distribution |
| 14-583335 | 4.75 TI 5.5X35MM CLOSED MAS | In distribution |
| 14-581030 | 4.75 TI SMALL MIDSTEM HOOK | In distribution |
| 14-584522 | 4.75 TI 6.5X22.5MM FIXED SCREW | In distribution |
| 14-588520CL | 4.75/5.5X200MM COCR LOW ROD | In distribution |
| 14-583222 | 4.75 TI 5.0X22.5MM CLOSED MAS | In distribution |
| 14-584441 | 4.75 TI 6.0X125MM FIXED SCREW | In distribution |
| 14-584846 | 4.75 TI 8.5X130MM FIXED SCREW | In distribution |
| 14-583923 | 4.75 TI 10.5X22.5MM CLOSED MAS | In distribution |
| 14-584967 | 4.75 TI 9.5X150MM FIXED SCREW | In distribution |
| 14-584948 | 4.75 TI 10.5X130MM FIXED SCREW | In distribution |
| 14-584166 | 4.75 TI 4.5X150MM FIXED SCREW | In distribution |
| 14-582150 | 4.75 TI 4.5X50MM MAS | In distribution |
| 14-584251 | 4.75 TI 5.0X135MM FIXED SCREW | In distribution |
| 14-587330CH | 4.75X300MM COCR HI LS CRV ROD | In distribution |
| 14-583056 | 4.75 TI 4.0X140MM CLOSED MAS | In distribution |
| 14-585103CS | 4.5X30MM COCR STD HEX ROD | In distribution |
| 14-582060 | 4.75 TI 4.0X60MM MAS | In distribution |
| 14-584122 | 4.75 TI 4.5X22.5MM FIXED SCREW | In distribution |
| 14-582326 | 4.75 TI 5.5X110MM MAS | In distribution |
| 14-583622 | 4.75 TI 7.0X22.5MM CLOSED MAS | In distribution |
| 14-584580 | 4.75 TI 6.5X80MM FIXED SCREW | In distribution |
| 14-583920 | 4.75 TI 9.5X20MM CLOSED MAS | In distribution |
| 14-582855 | 4.75 TI 8.5X55MM MAS | In distribution |
| 14-584556 | 4.75 TI 6.5X140MM FIXED SCREW | In distribution |
| 14-582465 | 4.75 TI 6.0X65MM MAS | In distribution |
| 14-582840 | 4.75 TI 8.5X40MM MAS | In distribution |
| 14-582470 | 4.75 TI 6.0X70MM MAS | In distribution |
| 14-589634 | 4.75 TI CLSD DOMINO, 4.75/4.75 | In distribution |
| 14-589507 | 4.75 TI SMALL ANG CROSS CONN | In distribution |
| 14-583421 | 4.75 TI 6.0X105MM CLOSED MAS | In distribution |
| 14-583531 | 4.75 TI 6.5X115MM CLOSED MAS | In distribution |
| 14-587260CL | 4.75X600MM COCR LOW MR CRV ROD | In distribution |
| 14-586530T | 4.5/5.5X300MM TI ALLOY ROD | In distribution |
| 14-583485 | 4.75 TI 6.0X85MM CLOSED MAS | In distribution |
| 14-582841 | 4.75 TI 8.5X125MM MAS | In distribution |
| 14-582880 | 4.75 TI 8.5X80MM MAS | In distribution |
| 14-583946 | 4.75 TI 10.5X45MM CLOSED MAS | In distribution |
| 14-582928 | 4.75 TI 10.5X27.5MM MAS | In distribution |
| 14-583830 | 4.75 TI 8.5X30MM CLOSED MAS | In distribution |
| 14-582950 | 4.75 TI 9.5X50MM MAS | In distribution |
| 14-584964 | 4.75 TI 10.5X145MM FIXED SCREW | In distribution |
| 14-583236 | 4.75 TI 5.0X120MM CLOSED MAS | In distribution |
| 14-584924 | 4.75 TI 9.5X105MM FIXED SCREW | In distribution |
| 14-582795 | 4.75 TI 7.5X95MM MAS | In distribution |
| 14-582756 | 4.75 TI 7.5X140MM MAS | In distribution |
| 14-582620 | 4.75 TI 7.0X20MM MAS | In distribution |
| 14-585230CL | 4.5X300MM COCR LOW MR CRV ROD | In distribution |
| 14-582080 | 4.75 TI 4.0X80MM MAS | In distribution |
| 14-583736 | 4.75 TI 7.5X120MM CLOSED MAS | In distribution |
| 14-584331 | 4.75 TI 5.5X115MM FIXED SCREW | In distribution |
| 14-584050 | 4.75 TI 4.0X50MM FIXED SCREW | In distribution |
| 14-587330CL | 4.75X300MM COCR LOW LS CRV ROD | In distribution |
| 14-581645L | 4.75 TI MED LFT OFFSET HOOK | In distribution |
| 14-583320 | 4.75 TI 5.5X20MM CLOSED MAS | In distribution |
| 14-586430CL | 4.5/4.75X300MM COCR LOW ROD | In distribution |
| 14-582926 | 4.75 TI 10.5X25MM MAS | 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.