Polaris 4.75 TI Spinal System
208 catalogue numbers from 14-583530, listed by Biomet Spine, United States, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
208catalogue 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, Spinal Pedicle Fixation
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle 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 |
|---|---|---|
| 14-583530 | 4.75 TI 6.5X30MM CLOSED MAS | In distribution |
| 14-582761 | 4.75 TI 7.5X145MM MAS | In distribution |
| 14-582336 | 4.75 TI 5.5X120MM MAS | In distribution |
| 14-583450 | 4.75 TI 6.0X50MM CLOSED MAS | In distribution |
| 14-583556 | 4.75 TI 6.5X140MM CLOSED MAS | In distribution |
| 14-582861 | 4.75 TI 8.5X145MM MAS | In distribution |
| 14-587360CH | 4.75X600MM COCR HI LS CRV ROD | In distribution |
| 14-583180 | 4.75 TI 4.5X80MM CLOSED MAS | In distribution |
| 14-582856 | 4.75 TI 8.5X140MM MAS | In distribution |
| 14-584999 | 4.75 TI 9.5X100MM FIXED SCREW | In distribution |
| 14-583031 | 4.75 TI 4.0X115MM CLOSED MAS | In distribution |
| 14-582322 | 4.75 TI 5.5X22.5MM MAS | In distribution |
| 14-587213CL | 4.75X130MM COCR LOW MR CRV ROD | In distribution |
| 14-589676 | 4.75 TI OPEN DOMINO, 4.75/6.35 | In distribution |
| 14-583947 | 4.75 TI 9.5X130MM CLOSED MAS | In distribution |
| 14-585230T | 4.5X300MM TI ALLOY MR CRV ROD | In distribution |
| 14-583041 | 4.75 TI 4.0X125MM CLOSED MAS | In distribution |
| 14-584340 | 4.75 TI 5.5X40MM FIXED SCREW | In distribution |
| 14-584385 | 4.75 TI 5.5X85MM FIXED SCREW | In distribution |
| 14-582156 | 4.75 TI 4.5X140MM MAS | In distribution |
| 14-586560CS | 4.5/5.5X600MM COCR STD ROD | In distribution |
| 14-582140 | 4.75 TI 4.5X40MM MAS | In distribution |
| 14-584099 | 4.75 TI 4.0X100MM FIXED SCREW | In distribution |
| 14-584721 | 4.75 TI 7.5X105MM FIXED SCREW | In distribution |
| 14-581590 | 4.75 TI 9MM REDUC LAM HOOK | In distribution |
| 14-584266 | 4.75 TI 5.0X150MM FIXED SCREW | In distribution |
| 14-589704 | 4.75 TI OFFSET CONNECTOR, LG | In distribution |
| 14-580912N | 4.75TI 12.5MM UNIV HK NO SPIKE | In distribution |
| 14-584730 | 4.75 TI 7.5X30MM FIXED SCREW | In distribution |
| 14-580911N | 4.75TI 11MM UNIV HK NO SPIKE | In distribution |
| 14-583996 | 4.75 TI 10.5X95MM CLOSED MAS | In distribution |
| 14-583035 | 4.75 TI 4.0X35MM CLOSED MAS | In distribution |
| 14-584751 | 4.75 TI 7.5X135MM FIXED SCREW | In distribution |
| 14-582455 | 4.75 TI 6.0X55MM MAS | In distribution |
| 14-582050 | 4.75 TI 4.0X50MM MAS | In distribution |
| 14-584551 | 4.75 TI 6.5X135MM FIXED SCREW | In distribution |
| 14-581640R | 4.75 TI 4MM RT OFFSET HOOK | In distribution |
| 14-584971 | 4.75 TI 10.5X70MM FIXED SCREW | In distribution |
| 14-582625 | 4.75 TI 7.0X25MM MAS | In distribution |
| 14-581175 | 4.75 TI 7.5MM PEDICLE HOOK | In distribution |
| 14-582040 | 4.75 TI 4.0X40MM MAS | In distribution |
| 14-583650 | 4.75 TI 7.0X50MM CLOSED MAS | In distribution |
| 14-582966 | 4.75 TI 10.5X65MM MAS | In distribution |
| 14-584756 | 4.75 TI 7.5X140MM FIXED SCREW | In distribution |
| 14-584845 | 4.75 TI 8.5X45MM FIXED SCREW | In distribution |
| 14-584546 | 4.75 TI 6.5X130MM FIXED SCREW | In distribution |
| 14-584899 | 4.75 TI 8.5X100MM FIXED SCREW | In distribution |
| 14-584821 | 4.75 TI 8.5X105MM FIXED SCREW | In distribution |
| 14-583655 | 4.75 TI 7.0X55MM CLOSED MAS | In distribution |
| 14-589799 | 4.75 TI OPEN CONN SET SCREW | In distribution |
| 14-582225 | 4.75 TI 5.0X25MM MAS | In distribution |
| 14-584299 | 4.75 TI 5.0X100MM FIXED SCREW | In distribution |
| 14-585360T | 4.5X600MM TI ALLOY LS CRV ROD | In distribution |
| 14-582561 | 4.75 TI 6.5X145MM MAS | In distribution |
| 14-583966 | 4.75 TI 10.5X65MM CLOSED MAS | In distribution |
| 14-586451T | 4.5/4.75X510MM TI ALLOY ROD | In distribution |
| 14-582566 | 4.75 TI 6.5X150MM MAS | In distribution |
| 14-584996 | 4.75 TI 10.5X95MM FIXED SCREW | In distribution |
| 14-581250L | 4.75 TI 5MM LEFT ANGLED HOOK | In distribution |
| 14-584356 | 4.75 TI 5.5X140MM FIXED SCREW | In distribution |
| 14-584995 | 4.75 TI 9.5X95MM FIXED SCREW | In distribution |
| 14-582445 | 4.75 TI 6.0X45MM MAS | In distribution |
| 14-583855 | 4.75 TI 8.5X55MM CLOSED MAS | In distribution |
| 14-582899 | 4.75 TI 8.5X100MM MAS | In distribution |
| 14-583950 | 4.75 TI 9.5X50MM CLOSED MAS | In distribution |
| 14-583963 | 4.75 TI 9.5X145MM CLOSED MAS | In distribution |
| 14-583225 | 4.75 TI 5.0X25MM CLOSED MAS | In distribution |
| 14-582985 | 4.75 TI 9.5X85MM MAS | In distribution |
| 14-582226 | 4.75 TI 5.0X110MM MAS | In distribution |
| 14-580910 | 4.75 TI 10.5MM UNIVERSAL HOOK | In distribution |
| 14-582099 | 4.75 TI 4.0X100MM MAS | In distribution |
| 14-584226 | 4.75 TI 5.0X110MM FIXED SCREW | In distribution |
| 14-583527 | 4.75 TI 6.5X27.5MM CLOSED MAS | In distribution |
| 14-583521 | 4.75 TI 6.5X105MM CLOSED MAS | In distribution |
| 14-583850 | 4.75 TI 8.5X50MM CLOSED MAS | In distribution |
| 14-580906N | 4.75 TI 6MM UNIV HOOK NO SPIKE | In distribution |
| 14-583350 | 4.75 TI 5.5X50MM CLOSED MAS | In distribution |
| 14-583385 | 4.75 TI 5.5X85MM CLOSED MAS | In distribution |
| 14-583795 | 4.75 TI 7.5X95MM CLOSED MAS | In distribution |
| 14-589310 | 4.75 TI 100MM LESS CRV AX CONN | In distribution |
| 14-582299 | 4.75 TI 5.0X100MM MAS | In distribution |
| 14-588551T | 4.75/5.5X510MM TI ALLOY ROD | In distribution |
| 14-588560CH | 4.75/5.5X600MM COCR HIGH ROD | In distribution |
| 14-589091 | 4.75 TI SMALL PELVIC SADDLE | In distribution |
| 14-583226 | 4.75 TI 5.0X110MM CLOSED MAS | In distribution |
| 14-583055 | 4.75 TI 4.0X55MM CLOSED MAS | In distribution |
| 14-587260CS | 4.75X600MM COCR STD MR CRV ROD | In distribution |
| 14-581545 | 4.75 TI MED REDUC LAM HOOK | In distribution |
| 14-584256 | 4.75 TI 5.0X140MM FIXED SCREW | In distribution |
| 14-587151CS | 4.75X510MM COCR STD HEX ROD | In distribution |
| 14-588520T | 4.75/5.5X200MM TI ALLOY ROD | In distribution |
| 14-582135 | 4.75 TI 4.5X35MM MAS | In distribution |
| 14-583430 | 4.75 TI 6.0X30MM CLOSED MAS | In distribution |
| 14-587351T | 4.75X510MM TI ALLOY LS CRV ROD | In distribution |
| 14-582721 | 4.75 TI 7.5X105MM MAS | In distribution |
| 14-582967 | 4.75 TI 9.5X150MM MAS | In distribution |
| 14-583750 | 4.75 TI 7.5X50MM CLOSED MAS | In distribution |
| 14-583346 | 4.75 TI 5.5X130MM CLOSED MAS | In distribution |
| 14-583150 | 4.75 TI 4.5X50MM CLOSED MAS | In distribution |
| 14-584231 | 4.75 TI 5.0X115MM FIXED SCREW | In distribution |
| 14-584622 | 4.75 TI 7.0X22.5MM FIXED SCREW | In distribution |
| 14-585260CH | 4.5X600MM COCR HI MR CRV ROD | In distribution |
| 14-582546 | 4.75 TI 6.5X130MM MAS | In distribution |
| 14-584675 | 4.75 TI 7.0X75MM FIXED SCREW | In distribution |
| 14-583685 | 4.75 TI 7.0X85MM CLOSED MAS | In distribution |
| 14-582846 | 4.75 TI 8.5X130MM MAS | In distribution |
| 14-584937 | 4.75 TI 9.5X120MM FIXED SCREW | In distribution |
| 14-582821 | 4.75 TI 8.5X105MM MAS | In distribution |
| 14-582964 | 4.75 TI 10.5X145MM MAS | In distribution |
| 14-584151 | 4.75 TI 4.5X135MM FIXED SCREW | In distribution |
| 14-583021 | 4.75 TI 4.0X105MM CLOSED MAS | In distribution |
| 14-589712 | 4.75 TI OFFSET CONNECTOR, 25MM | In distribution |
| 14-580916 | 4.75 TI 16MM UNIVERSAL HOOK | In distribution |
| 14-582221 | 4.75 TI 5.0X105MM MAS | In distribution |
| 14-583561 | 4.75 TI 6.5X145MM CLOSED MAS | In distribution |
| 14-583085 | 4.75 TI 4.0X85MM CLOSED MAS | In distribution |
| 14-583721 | 4.75 TI 7.5X105MM CLOSED MAS | In distribution |
| 14-583585 | 4.75 TI 6.5X85MM CLOSED MAS | In distribution |
| 14-584451 | 4.75 TI 6.0X135MM FIXED SCREW | In distribution |
| 14-583755 | 4.75 TI 7.5X55MM CLOSED MAS | In distribution |
| 14-586445CS | 4.5/4.75X450MM COCR STD ROD | In distribution |
| 14-584865 | 4.75 TI 8.5X65MM FIXED SCREW | In distribution |
| 14-581660L | 4.75 TI LARGE LFT OFFSET HOOK | In distribution |
| 14-584590 | 4.75 TI 6.5X90MM FIXED SCREW | In distribution |
| 14-584932 | 4.75 TI 10.5X105MM FIXED SCREW | In distribution |
| 14-584957 | 4.75 TI 9.5X140MM FIXED SCREW | In distribution |
| 14-583991 | 4.75 TI 10.5X90MM CLOSED MAS | In distribution |
| 14-582685 | 4.75 TI 7.0X85MM MAS | In distribution |
| 14-583495 | 4.75 TI 6.0X95MM CLOSED MAS | In distribution |
| 14-585151CS | 4.5X510MM COCR STD HEX ROD | In distribution |
| 14-584631 | 4.75 TI 7.0X115MM FIXED SCREW | In distribution |
| 14-582122 | 4.75 TI 4.5X22.5MM MAS | In distribution |
| 14-582499 | 4.75 TI 6.0X100MM MAS | In distribution |
| 14-583680 | 4.75 TI 7.0X80MM CLOSED MAS | In distribution |
| 14-583627 | 4.75 TI 7.0X27.5MM CLOSED MAS | In distribution |
| 14-587351CH | 4.75X510MM COCR HI LS CRV ROD | In distribution |
| 14-581090 | 4.75 TI 9MM MIDSTEM HOOK | In distribution |
| 14-582199 | 4.75 TI 4.5X100MM MAS | In distribution |
| 14-585245CS | 4.5X450MM COCR STD MR CRV ROD | In distribution |
| 14-588520CH | 4.75/5.5X200MM COCR HIGH ROD | In distribution |
| 14-583720 | 4.75 TI 7.5X20MM CLOSED MAS | In distribution |
| 14-584336 | 4.75 TI 5.5X120MM FIXED SCREW | In distribution |
| 14-584761 | 4.75 TI 7.5X145MM FIXED SCREW | In distribution |
| 14-582595 | 4.75 TI 6.5X95MM MAS | In distribution |
| 14-584131 | 4.75 TI 4.5X115MM FIXED SCREW | In distribution |
| 14-582951 | 4.75 TI 10.5X50MM MAS | In distribution |
| 14-582051 | 4.75 TI 4.0X135MM MAS | In distribution |
| 14-582531 | 4.75 TI 6.5X115MM MAS | In distribution |
| 14-582355 | 4.75 TI 5.5X55MM MAS | In distribution |
| 14-583151 | 4.75 TI 4.5X135MM CLOSED MAS | In distribution |
| 14-588530CH | 4.75/5.5X300MM COCR HIGH ROD | In distribution |
| 14-583022 | 4.75 TI 4.0X22.5MM CLOSED MAS | In distribution |
| 14-583656 | 4.75 TI 7.0X140MM CLOSED MAS | In distribution |
| 14-583030 | 4.75 TI 4.0X30MM CLOSED MAS | In distribution |
| 14-583522 | 4.75 TI 6.5X22.5MM CLOSED MAS | In distribution |
| 14-584121 | 4.75 TI 4.5X105MM FIXED SCREW | In distribution |
| 14-582975 | 4.75 TI 9.5X75MM MAS | In distribution |
| 14-582730 | 4.75 TI 7.5X30MM MAS | In distribution |
| 14-583125 | 4.75 TI 4.5X25MM CLOSED MAS | In distribution |
| 14-582420 | 4.75 TI 6.0X20MM MAS | In distribution |
| 14-582636 | 4.75 TI 7.0X120MM MAS | In distribution |
| 14-584465 | 4.75 TI 6.0X65MM FIXED SCREW | In distribution |
| 14-582827 | 4.75 TI 8.5X27.5MM MAS | In distribution |
| 14-584246 | 4.75 TI 5.0X130MM FIXED SCREW | In distribution |
| 14-583060 | 4.75 TI 4.0X60MM CLOSED MAS | In distribution |
| 14-584943 | 4.75 TI 9.5X125MM FIXED SCREW | In distribution |
| 14-583856 | 4.75 TI 8.5X140MM CLOSED MAS | In distribution |
| 14-584661 | 4.75 TI 7.0X145MM FIXED SCREW | In distribution |
| 14-584430 | 4.75 TI 6.0X30MM FIXED SCREW | In distribution |
| 14-585351T | 4.5X510MM TI ALLOY LS CRV ROD | In distribution |
| 14-584490 | 4.75 TI 6.0X90MM FIXED SCREW | In distribution |
| 14-582380 | 4.75 TI 5.5X80MM MAS | In distribution |
| 14-589506 | 4.75 TI XS ANG CROSS CONN | In distribution |
| 14-582936 | 4.75 TI 10.5X35MM MAS | In distribution |
| 14-589704R | 4.75 TI RIGHT OFFSET CONN, LG | In distribution |
| 14-582056 | 4.75 TI 4.0X140MM MAS | In distribution |
| 14-582943 | 4.75 TI 9.5X125MM MAS | In distribution |
| 14-583846 | 4.75 TI 8.5X130MM CLOSED MAS | In distribution |
| 14-587345CH | 4.75X450MM COCR HI LS CRV ROD | In distribution |
| 14-582095 | 4.75 TI 4.0X95MM MAS | In distribution |
| 14-589702L | 4.75 TI LEFT OFFSET CONN, SM | In distribution |
| 14-582522 | 4.75 TI 6.5X22.5MM MAS | In distribution |
| 14-583422 | 4.75 TI 6.0X22.5MM CLOSED MAS | In distribution |
| 14-582061 | 4.75 TI 4.0X145MM MAS | In distribution |
| 14-582971 | 4.75 TI 10.5X70MM MAS | In distribution |
| 14-583299 | 4.75 TI 5.0X100MM CLOSED MAS | In distribution |
| 14-582766 | 4.75 TI 7.5X150MM MAS | In distribution |
| 14-587313CL | 4.75X130MM COCR LOW LS CRV ROD | In distribution |
| 14-583436 | 4.75 TI 6.0X120MM CLOSED MAS | In distribution |
| 14-583999 | 4.75 TI 9.5X100MM CLOSED MAS | In distribution |
| 14-584670 | 4.75 TI 7.0X70MM FIXED SCREW | In distribution |
| 14-583566 | 4.75 TI 6.5X150MM CLOSED MAS | In distribution |
| 14-583127 | 4.75 TI 4.5X27.5MM CLOSED MAS | In distribution |
| 14-588545CH | 4.75/5.5X450MM COCR HIGH ROD | In distribution |
| 14-584350 | 4.75 TI 5.5X50MM FIXED SCREW | In distribution |
| 14-584136 | 4.75 TI 4.5X120MM FIXED SCREW | In distribution |
| 14-589212 | 4.75 TI 120MM MORE CRV AX CONN | In distribution |
| 14-581275L | 4.75 TI 7.5MM LEFT ANGLED HOOK | In distribution |
| 14-582395 | 4.75 TI 5.5X95MM MAS | In distribution |
| 14-581635L | 4.75 TI 3.5MM LEFT OFFSET HOOK | In distribution |
| 14-581850 | 4.75 TI 5MM EXTENDED HOOK | In distribution |
| 14-581445 | 4.75 TI MED LAMINAR HOOK | In distribution |
| 14-582765 | 4.75 TI 7.5X65MM MAS | In distribution |
| 14-584240 | 4.75 TI 5.0X40MM FIXED SCREW | In distribution |
| 14-585151T | 4.75X510MM TI ALLOY HEX ROD | In distribution |
| 14-584420 | 4.75 TI 6.0X20MM FIXED SCREW | In distribution |
| 14-587160CL | 4.75X600MM COCR LOW HEX ROD | In distribution |
| 14-582924 | 4.75 TI 9.5X105MM MAS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle 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.