Polaris 4.75 TI Spinal System

256 catalogue numbers from 14-584436, listed by Biomet Spine, United States, under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
256catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OSH
Manufacturer City Province Registered as Device types
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
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
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34

Record

Regulatory record for Polaris 4.75 TI Spinal System
Listed by Biomet Spine, United States
FDA product code OSH
Device type Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device class Class 2
Regulation 21 CFR 888.3070
Record published 2015-10-24
Record revised 2025-07-02 (version 6)

Specifications

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 numbers for Polaris 4.75 TI Spinal System
Catalogue number Size Status
14-584436 4.75 TI 6.0X120MM FIXED SCREW In distribution
14-582565 4.75 TI 6.5X65MM MAS In distribution
14-589308 4.75 TI 80MM LESS CRV AX CONN In distribution
14-584939 4.75 TI 10.5X110MM FIXED SCREW In distribution
14-583399 4.75 TI 5.5X100MM CLOSED MAS In distribution
14-583928 4.75 TI 10.5X27.5MM CLOSED MAS In distribution
14-583250 4.75 TI 5.0X50MM CLOSED MAS In distribution
14-583141 4.75 TI 4.5X125MM CLOSED MAS In distribution
14-583740 4.75 TI 7.5X40MM CLOSED MAS In distribution
14-583666 4.75 TI 7.0X150MM CLOSED MAS In distribution
14-582655 4.75 TI 7.0X55MM MAS In distribution
14-582954 4.75 TI 10.5X135MM MAS In distribution
14-582450 4.75 TI 6.0X50MM MAS In distribution
14-586545T 4.5/5.5X450MM TI ALLOY ROD In distribution
14-584625 4.75 TI 7.0X25MM FIXED SCREW In distribution
14-582120 4.75 TI 4.5X20MM MAS In distribution
14-582931 4.75 TI 10.5X30MM MAS In distribution
14-582285 4.75 TI 5.0X85MM MAS In distribution
14-586460CH 4.5/4.75X600MM COCR HIGH ROD In distribution
14-582255 4.75 TI 5.0X55MM MAS In distribution
14-583930 4.75 TI 9.5X30MM CLOSED MAS In distribution
14-584241 4.75 TI 5.0X125MM FIXED SCREW In distribution
14-584770 4.75 TI 7.5X70MM FIXED SCREW In distribution
14-584195 4.75 TI 4.5X95MM FIXED SCREW In distribution
14-584822 4.75 TI 8.5X22.5MM FIXED SCREW In distribution
14-584126 4.75 TI 4.5X110MM FIXED SCREW In distribution
14-582890 4.75 TI 8.5X90MM MAS In distribution
14-583370 4.75 TI 5.5X70MM CLOSED MAS In distribution
14-582475 4.75 TI 6.0X75MM MAS In distribution
14-582131 4.75 TI 4.5X115MM MAS In distribution
14-585145CL 4.5X450MM COCR LOW HEX ROD In distribution
14-584120 4.75 TI 4.5X20MM FIXED SCREW In distribution
14-587151CH 4.75X510MM COCR HIGH HEX ROD In distribution
14-583651 4.75 TI 7.0X135MM CLOSED MAS In distribution
14-583025 4.75 TI 4.0X25MM CLOSED MAS In distribution
14-582446 4.75 TI 6.0X130MM MAS In distribution
14-584035 4.75 TI 4.0X35MM FIXED SCREW In distribution
14-582536 4.75 TI 6.5X120MM MAS In distribution
14-584440 4.75 TI 6.0X40MM FIXED SCREW In distribution
14-584745 4.75 TI 7.5X45MM FIXED SCREW In distribution
14-584640 4.75 TI 7.0X40MM FIXED SCREW In distribution
14-582722 4.75 TI 7.5X22.5MM MAS In distribution
14-582627 4.75 TI 7.0X27.5MM MAS In distribution
14-582236 4.75 TI 5.0X120MM MAS In distribution
14-583135 4.75 TI 4.5X35MM CLOSED MAS In distribution
14-589835 4.75 TI 35MM BRIDGE CONN In distribution
14-584022 4.75 TI 4.0X22.5MM FIXED SCREW In distribution
14-587145CS 4.75X450MM COCR STD HEX ROD In distribution
14-584926 4.75 TI 10.5X25MM FIXED SCREW In distribution
14-583290 4.75 TI 5.0X90MM CLOSED MAS In distribution
14-583735 4.75 TI 7.5X35MM CLOSED MAS In distribution
14-584066 4.75 TI 4.0X150MM FIXED SCREW In distribution
14-583646 4.75 TI 7.0X130MM CLOSED MAS In distribution
14-580908 4.75 TI 8.5MM UNIVERSAL HOOK In distribution
14-582725 4.75 TI 7.5X25MM MAS In distribution
14-581750 4.75 TI 5MM ANG BLADE HOOK In distribution
14-582526 4.75 TI 6.5X110MM MAS In distribution
14-589705L 4.75 TI LEFT OFFSET CONN, XL In distribution
14-584540 4.75 TI 6.5X40MM FIXED SCREW In distribution
14-580921 4.75 TI LG UNIV CLOSING HOOK In distribution
14-584958 4.75 TI 10.5X140MM FIXED SCREW In distribution
14-585251CL 4.5X510MM COCR LOW MR CRV ROD In distribution
14-586560CH 4.5/5.5X600MM COCR HIGH ROD In distribution
14-583822 4.75 TI 8.5X22.5MM CLOSED MAS In distribution
14-582945 4.75 TI 9.5X45MM MAS In distribution
14-586430CH 4.5/4.75X300MM COCR HIGH ROD In distribution
14-583099 4.75 TI 4.0X100MM CLOSED MAS In distribution
14-582585 4.75 TI 6.5X85MM MAS In distribution
14-583580 4.75 TI 6.5X80MM CLOSED MAS In distribution
14-582151 4.75 TI 4.5X135MM MAS In distribution
14-583325 4.75 TI 5.5X25MM CLOSED MAS In distribution
14-583760 4.75 TI 7.5X60MM CLOSED MAS In distribution
14-584070 4.75 TI 4.0X70MM FIXED SCREW In distribution
14-584541 4.75 TI 6.5X125MM FIXED SCREW In distribution
14-582530 4.75 TI 6.5X30MM MAS In distribution
14-584960 4.75 TI 9.5X60MM FIXED SCREW In distribution
14-583899 4.75 TI 8.5X100MM CLOSED MAS In distribution
14-584795 4.75 TI 7.5X95MM FIXED SCREW In distribution
14-584765 4.75 TI 7.5X65MM FIXED SCREW In distribution
14-584836 4.75 TI 8.5X120MM FIXED SCREW In distribution
14-582932 4.75 TI 10.5X105MM MAS In distribution
14-589208 4.75 TI 80MM MORE CRV AX CONN In distribution
14-582075 4.75 TI 4.0X75MM MAS In distribution
14-580915 4.75 TI 15MM UNIVERSAL HOOK In distribution
14-583265 4.75 TI 5.0X65MM CLOSED MAS In distribution
14-587145CH 4.75X450MM COCR HIGH HEX ROD In distribution
14-584065 4.75 TI 4.0X65MM FIXED SCREW In distribution
14-584321 4.75 TI 5.5X105MM FIXED SCREW In distribution
14-581835 4.75 TI 3.5MM EXTENDED HOOK In distribution
14-582575 4.75 TI 6.5X75MM MAS In distribution
14-585213CL 4.5X130MM COCR LOW MR CRV ROD In distribution
14-584946 4.75 TI 10.5X45MM FIXED SCREW In distribution
14-583990 4.75 TI 9.5X90MM CLOSED MAS In distribution
14-584530 4.75 TI 6.5X30MM FIXED SCREW In distribution
14-587345T 4.75X450MM TI ALLOY LS CRV ROD In distribution
14-584880 4.75 TI 8.5X80MM FIXED SCREW In distribution
14-584499 4.75 TI 6.0X100MM FIXED SCREW In distribution
14-583251 4.75 TI 5.0X135MM CLOSED MAS In distribution
14-582485 4.75 TI 6.0X85MM MAS In distribution
14-582895 4.75 TI 8.5X95MM MAS In distribution
14-583935 4.75 TI 9.5X35MM CLOSED MAS In distribution
14-584046 4.75 TI 4.0X130MM FIXED SCREW In distribution
14-584027 4.75 TI 4.0X27.5MM FIXED SCREW In distribution
14-585345CL 4.5X450MM COCR LOW LS CRV ROD In distribution
14-584421 4.75 TI 6.0X105MM FIXED SCREW In distribution
14-582735 4.75 TI 7.5X35MM MAS In distribution
14-581075 4.75 TI 7.5MM MIDSTEM HOOK In distribution
14-582695 4.75 TI 7.0X95MM MAS In distribution
14-582170 4.75 TI 4.5X70MM MAS In distribution
14-582960 4.75 TI 9.5X60MM MAS In distribution
14-586430T 4.5/4.75X300MM TI ALLOY ROD In distribution
14-583631 4.75 TI 7.0X115MM CLOSED MAS In distribution
14-582755 4.75 TI 7.5X55MM MAS In distribution
14-581230L 4.75 TI SMALL LFT ANG HOOK In distribution
14-584140 4.75 TI 4.5X40MM FIXED SCREW In distribution
14-588551CL 4.75/5.5X510MM COCR LOW ROD In distribution
14-583927 4.75 TI 9.5X27.5MM CLOSED MAS In distribution
14-584785 4.75 TI 7.5X85MM FIXED SCREW In distribution
14-584427 4.75 TI 6.0X27.5MM FIXED SCREW In distribution
14-589705 4.75 TI OFFSET CONNECTOR, XL In distribution
14-582385 4.75 TI 5.5X85MM MAS In distribution
14-583131 4.75 TI 4.5X115MM CLOSED MAS In distribution
14-580913 4.75 TI 13.5MM UNIVERSAL HOOK In distribution
14-584051 4.75 TI 4.0X135MM FIXED SCREW In distribution
14-583851 4.75 TI 8.5X135MM CLOSED MAS In distribution
14-582556 4.75 TI 6.5X140MM MAS In distribution
14-582527 4.75 TI 6.5X27.5MM MAS In distribution
14-582021 4.75 TI 4.0X105MM MAS In distribution
14-583027 4.75 TI 4.0X27.5MM CLOSED MAS In distribution
14-585245T 4.5X450MM TI ALLOY MR CRV ROD In distribution
14-583095 4.75 TI 4.0X95MM CLOSED MAS In distribution
14-582235 4.75 TI 5.0X35MM MAS In distribution
14-582461 4.75 TI 6.0X145MM MAS In distribution
14-584061 4.75 TI 4.0X145MM FIXED SCREW In distribution
14-581630L 4.75 TI SMALL LFT OFFSET HOOK In distribution
14-589740 4.75 TI 40MM LAT CONN In distribution
14-584741 4.75 TI 7.5X125MM FIXED SCREW In distribution
14-580908N 4.75 TI 8.5MM UNIV HK NO SPIKE In distribution
14-583998 4.75 TI 10.5X100MM CLOSED MAS In distribution
14-584666 4.75 TI 7.0X150MM FIXED SCREW In distribution
14-584470 4.75 TI 6.0X70MM FIXED SCREW In distribution
14-584030 4.75 TI 4.0X30MM FIXED SCREW In distribution
14-582736 4.75 TI 7.5X120MM MAS In distribution
14-583861 4.75 TI 8.5X145MM CLOSED MAS In distribution
14-582027 4.75 TI 4.0X27.5MM MAS In distribution
14-583066 4.75 TI 4.0X150MM CLOSED MAS In distribution
14-584665 4.75 TI 7.0X65MM FIXED SCREW In distribution
14-582666 4.75 TI 7.0X150MM MAS In distribution
14-589875 4.75 TI 75MM BRIDGE CONN In distribution
14-585160CH 4.5X600MM COCR HIGH HEX ROD In distribution
14-585103CL 4.5X30MM COCR LOW HEX ROD In distribution
14-588520CS 4.75/5.5X200MM COCR STD ROD In distribution
14-582953 4.75 TI 9.5X135MM MAS In distribution
14-583199 4.75 TI 4.5X100MM CLOSED MAS In distribution
14-582920 4.75 TI 9.5X20MM MAS In distribution
14-583599 4.75 TI 6.5X100MM CLOSED MAS In distribution
14-582621 4.75 TI 7.0X105MM MAS In distribution
14-589092 4.75 TI LARGE PELVIC SADDLE In distribution
14-582090 4.75 TI 4.0X90MM MAS In distribution
14-582426 4.75 TI 6.0X110MM MAS In distribution
14-582125 4.75 TI 4.5X25MM MAS In distribution
14-589508 4.75 TI MED ANG CROSS CONN In distribution
14-582933 4.75 TI 9.5X115MM MAS In distribution
14-583535 4.75 TI 6.5X35MM CLOSED MAS In distribution
14-587345CL 4.75X450MM COCR LOW LS CRV ROD In distribution
14-582545 4.75 TI 6.5X45MM MAS In distribution
14-587351CL 4.75X510MM COCR LOW LS CRV ROD In distribution
14-583245 4.75 TI 5.0X45MM CLOSED MAS In distribution
14-587130CS 4.75X300MM COCR STD HEX ROD In distribution
14-584040 4.75 TI 4.0X40MM FIXED SCREW In distribution
14-582820 4.75 TI 8.5X20MM MAS In distribution
14-584561 4.75 TI 6.5X145MM FIXED SCREW In distribution
14-583390 4.75 TI 5.5X90MM CLOSED MAS In distribution
14-584090 4.75 TI 4.0X90MM FIXED SCREW In distribution
14-581035 4.75 TI 3.5MM MIDSTEM HOOK In distribution
14-584930 4.75 TI 9.5X30MM FIXED SCREW In distribution
14-583745 4.75 TI 7.5X45MM CLOSED MAS In distribution
14-583575 4.75 TI 6.5X75MM CLOSED MAS In distribution
14-584227 4.75 TI 5.0X27.5MM FIXED SCREW In distribution
14-582981 4.75 TI 10.5X80MM MAS In distribution
14-582580 4.75 TI 6.5X80MM MAS In distribution
14-583945 4.75 TI 9.5X45MM CLOSED MAS In distribution
14-584450 4.75 TI 6.0X50MM FIXED SCREW In distribution
14-583951 4.75 TI 10.5X50MM CLOSED MAS In distribution
14-585313T 4.5X130MM TI ALLOY LS CRV ROD In distribution
14-582025 4.75 TI 4.0X25MM MAS In distribution
14-584950 4.75 TI 9.5X50MM FIXED SCREW In distribution
14-584255 4.75 TI 5.0X55MM FIXED SCREW In distribution
14-589099 4.75 TI CLOSED CONN SET SCREW In distribution
14-583875 4.75 TI 8.5X75MM CLOSED MAS In distribution
14-583665 4.75 TI 7.0X65MM CLOSED MAS In distribution
14-582661 4.75 TI 7.0X145MM MAS In distribution
14-584651 4.75 TI 7.0X135MM FIXED SCREW In distribution
14-580907 4.75 TI 6.5MM UNIVERSAL HOOK In distribution
14-582630 4.75 TI 7.0X30MM MAS In distribution
14-584395 4.75 TI 5.5X95MM FIXED SCREW In distribution
14-586551T 4.5/5.5X510MM TI ALLOY ROD In distribution
14-582965 4.75 TI 9.5X65MM MAS In distribution
14-581240R 4.75 TI 4MM RIGHT ANGLED HOOK In distribution
14-583954 4.75 TI 10.5X135MM CLOSED MAS In distribution
14-585330CH 4.5X300MM COCR HI LS CRV ROD In distribution
14-582590 4.75 TI 6.5X90MM MAS In distribution
14-582480 4.75 TI 6.0X80MM MAS In distribution
14-582921 4.75 TI 10.5X20MM MAS In distribution
14-583690 4.75 TI 7.0X90MM CLOSED MAS In distribution
14-584934 4.75 TI 10.5X115MM FIXED SCREW In distribution
14-584056 4.75 TI 4.0X140MM FIXED SCREW In distribution
14-583865 4.75 TI 8.5X65MM CLOSED MAS In distribution
14-582340 4.75 TI 5.5X40MM MAS In distribution
14-586545CH 4.5/5.5X450MM COCR HIGH ROD In distribution
14-585230CH 4.5X300MM COCR HI MR CRV ROD In distribution
14-584720 4.75 TI 7.5X20MM FIXED SCREW In distribution
14-588560CS 4.75/5.5X600MM COCR STD ROD In distribution
14-582645 4.75 TI 7.0X45MM MAS In distribution
14-584933 4.75 TI 9.5X115MM FIXED SCREW In distribution
14-583050 4.75 TI 4.0X50MM CLOSED MAS In distribution
14-584521 4.75 TI 6.5X105MM FIXED SCREW In distribution
14-582790 4.75 TI 7.5X90MM MAS In distribution
14-584330 4.75 TI 5.5X30MM FIXED SCREW In distribution
14-582955 4.75 TI 9.5X55MM MAS In distribution
14-584731 4.75 TI 7.5X115MM FIXED SCREW In distribution
14-586551CS 4.5/5.5X510MM COCR STD ROD In distribution
14-582925 4.75 TI 9.5X25MM MAS In distribution
14-583555 4.75 TI 6.5X55MM CLOSED MAS In distribution
14-585260CL 4.5X600MM COCR LOW MR CRV ROD In distribution
14-584199 4.75 TI 4.5X100MM FIXED SCREW In distribution
14-584325 4.75 TI 5.5X25MM FIXED SCREW In distribution
14-583932 4.75 TI 10.5X105MM CLOSED MAS In distribution
14-589512 4.75 TI 12MM FIXED CROSS CONN In distribution
14-581430 4.75 TI SMALL LAMINAR HOOK In distribution
14-583360 4.75 TI 5.5X60MM CLOSED MAS In distribution
14-584966 4.75 TI 10.5X65MM FIXED SCREW In distribution
14-584425 4.75 TI 6.0X25MM FIXED SCREW In distribution
14-586530CS 4.5/5.5X300MM COCR STD ROD In distribution
14-583751 4.75 TI 7.5X135MM CLOSED MAS In distribution
14-582146 4.75 TI 4.5X130MM MAS In distribution
14-580915N 4.75 TI 15MM UNIV HK NO SPIKE In distribution
14-583526 4.75 TI 6.5X110MM CLOSED MAS In distribution
14-582490 4.75 TI 6.0X90MM MAS In distribution
14-583870 4.75 TI 8.5X70MM CLOSED MAS In distribution
14-584055 4.75 TI 4.0X55MM FIXED SCREW In distribution
14-588545CS 4.75/5.5X450MM COCR STD ROD In distribution
14-584621 4.75 TI 7.0X105MM FIXED SCREW In distribution
14-582330 4.75 TI 5.5X30MM MAS In distribution
14-583145 4.75 TI 4.5X45MM CLOSED MAS In distribution
14-582327 4.75 TI 5.5X27.5MM MAS In distribution
14-586451CH 4.5/4.75X510MM COCR HIGH ROD In distribution
14-582195 4.75 TI 4.5X95MM MAS In distribution
14-584520 4.75 TI 6.5X20MM FIXED SCREW In distribution
14-584170 4.75 TI 4.5X70MM FIXED SCREW In distribution

Showing 250 of 256 catalogue numbers.

Same Product Code

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Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer