Polaris 4.75 TI Spinal System
172 catalogue numbers from 14-582070, 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
172catalogue 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 | 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 |
|---|---|---|
| 14-582070 | 4.75 TI 4.0X70MM MAS | In distribution |
| 14-587230CH | 4.75X300MM COCR HI MR CRV ROD | In distribution |
| 14-587360CL | 4.75X600MM COCR LOW LS CRV ROD | In distribution |
| 14-583826 | 4.75 TI 8.5X110MM CLOSED MAS | In distribution |
| 14-583976 | 4.75 TI 10.5X75MM CLOSED MAS | In distribution |
| 14-581060 | 4.75 TI LARGE MIDSTEM HOOK | In distribution |
| 14-584835 | 4.75 TI 8.5X35MM FIXED SCREW | In distribution |
| 14-584160 | 4.75 TI 4.5X60MM FIXED SCREW | In distribution |
| 14-582550 | 4.75 TI 6.5X50MM MAS | In distribution |
| 14-583560 | 4.75 TI 6.5X60MM CLOSED MAS | In distribution |
| 14-584620 | 4.75 TI 7.0X20MM FIXED SCREW | In distribution |
| 14-584660 | 4.75 TI 7.0X60MM FIXED SCREW | In distribution |
| 14-589840 | 4.75 TI 40MM BRIDGE CONN | In distribution |
| 14-584975 | 4.75 TI 9.5X75MM FIXED SCREW | In distribution |
| 14-585113CS | 4.5X130MM COCR STD HEX ROD | In distribution |
| 14-581690L | 4.75 TI 9MM LEFT OFFSET HOOK | In distribution |
| 14-582991 | 4.75 TI 10.5X90MM MAS | In distribution |
| 14-582031 | 4.75 TI 4.0X115MM MAS | In distribution |
| 14-584031 | 4.75 TI 4.0X115MM FIXED SCREW | In distribution |
| 14-583166 | 4.75 TI 4.5X150MM CLOSED MAS | In distribution |
| 14-587160T | 4.75X600MM TI ALLOY HEX ROD | In distribution |
| 14-582775 | 4.75 TI 7.5X75MM MAS | In distribution |
| 14-582799 | 4.75 TI 7.5X100MM MAS | In distribution |
| 14-583175 | 4.75 TI 4.5X75MM CLOSED MAS | In distribution |
| 14-584685 | 4.75 TI 7.0X85MM FIXED SCREW | In distribution |
| 14-584968 | 4.75 TI 10.5X150MM FIXED SCREW | In distribution |
| 14-582996 | 4.75 TI 10.5X95MM MAS | In distribution |
| 14-587351CS | 4.75X510MM COCR STD LS CRV ROD | In distribution |
| 14-583375 | 4.75 TI 5.5X75MM CLOSED MAS | In distribution |
| 14-581135 | 4.75 TI 3.5MM PEDICLE HOOK | In distribution |
| 14-587313CS | 4.75X130MM COCR STD LS CRV ROD | In distribution |
| 14-582066 | 4.75 TI 4.0X150MM MAS | In distribution |
| 14-587230CS | 4.75X300MM COCR STD MR CRV ROD | In distribution |
| 14-583380 | 4.75 TI 5.5X80MM CLOSED MAS | In distribution |
| 14-584736 | 4.75 TI 7.5X120MM FIXED SCREW | In distribution |
| 14-584095 | 4.75 TI 4.0X95MM FIXED SCREW | In distribution |
| 14-582626 | 4.75 TI 7.0X110MM MAS | In distribution |
| 14-588551CH | 4.75/5.5X510MM COCR HIGH ROD | In distribution |
| 14-587251T | 4.75X510MM TI ALLOY MR CRV ROD | In distribution |
| 14-584320 | 4.75 TI 5.5X20MM FIXED SCREW | In distribution |
| 14-585351CH | 4.5X510MM COCR HI LS CRV ROD | In distribution |
| 14-582035 | 4.75 TI 4.0X35MM MAS | In distribution |
| 14-581450 | 4.75 TI 5MM LAMINAR HOOK | In distribution |
| 14-583980 | 4.75 TI 9.5X80MM CLOSED MAS | In distribution |
| 14-581735 | 4.75 TI 3.5MM ANG BLADE HOOK | In distribution |
| 14-584735 | 4.75 TI 7.5X35MM FIXED SCREW | In distribution |
| 14-584135 | 4.75 TI 4.5X35MM FIXED SCREW | In distribution |
| 14-583456 | 4.75 TI 6.0X140MM CLOSED MAS | In distribution |
| 14-585251CH | 4.5X510MM COCR HI MR CRV ROD | In distribution |
| 14-584938 | 4.75 TI 10.5X120MM FIXED SCREW | In distribution |
| 14-584841 | 4.75 TI 8.5X125MM FIXED SCREW | In distribution |
| 14-583075 | 4.75 TI 4.0X75MM CLOSED MAS | In distribution |
| 14-584560 | 4.75 TI 6.5X60MM FIXED SCREW | In distribution |
| 14-589001 | 4.75 TI STANDARD PLUG | In distribution |
| 14-583968 | 4.75 TI 10.5X150MM CLOSED MAS | In distribution |
| 14-585330T | 4.5X300MM TI ALLOY LS CRV ROD | In distribution |
| 14-584641 | 4.75 TI 7.0X125MM FIXED SCREW | In distribution |
| 14-581240L | 4.75 TI 4MM LEFT ANGLED HOOK | In distribution |
| 14-584945 | 4.75 TI 9.5X45MM FIXED SCREW | In distribution |
| 14-582535 | 4.75 TI 6.5X35MM MAS | In distribution |
| 14-583235 | 4.75 TI 5.0X35MM CLOSED MAS | In distribution |
| 14-584925 | 4.75 TI 9.5X25MM FIXED SCREW | In distribution |
| 14-584221 | 4.75 TI 5.0X105MM FIXED SCREW | In distribution |
| 14-584125 | 4.75 TI 4.5X25MM FIXED SCREW | In distribution |
| 14-582822 | 4.75 TI 8.5X22.5MM MAS | In distribution |
| 14-582261 | 4.75 TI 5.0X145MM MAS | In distribution |
| 14-582995 | 4.75 TI 9.5X95MM MAS | In distribution |
| 14-581435 | 4.75 TI 3.5MM LAMINAR HOOK | In distribution |
| 14-583620 | 4.75 TI 7.0X20MM CLOSED MAS | In distribution |
| 14-581660R | 4.75 TI LARGE RT OFFSET HOOK | In distribution |
| 14-581650R | 4.75 TI 5MM RT OFFSET HOOK | In distribution |
| 14-582831 | 4.75 TI 8.5X115MM MAS | In distribution |
| 14-584921 | 4.75 TI 10.5X20MM FIXED SCREW | In distribution |
| 14-589703 | 4.75 TI OFFSET CONNECTOR, M | In distribution |
| 14-582136 | 4.75 TI 4.5X120MM MAS | In distribution |
| 14-582155 | 4.75 TI 4.5X55MM MAS | In distribution |
| 14-582560 | 4.75 TI 6.5X60MM MAS | In distribution |
| 14-583635 | 4.75 TI 7.0X35MM CLOSED MAS | In distribution |
| 14-582321 | 4.75 TI 5.5X105MM MAS | In distribution |
| 14-582780 | 4.75 TI 7.5X80MM MAS | In distribution |
| 14-584646 | 4.75 TI 7.0X130MM FIXED SCREW | In distribution |
| 14-582175 | 4.75 TI 4.5X75MM MAS | In distribution |
| 14-584345 | 4.75 TI 5.5X45MM FIXED SCREW | In distribution |
| 14-583726 | 4.75 TI 7.5X110MM CLOSED MAS | In distribution |
| 14-584850 | 4.75 TI 8.5X50MM FIXED SCREW | In distribution |
| 14-584220 | 4.75 TI 5.0X20MM FIXED SCREW | In distribution |
| 14-583445 | 4.75 TI 6.0X45MM CLOSED MAS | In distribution |
| 14-587251CS | 4.75X510MM COCR STD MR CRV ROD | In distribution |
| 14-583957 | 4.75 TI 9.5X140MM CLOSED MAS | In distribution |
| 14-583266 | 4.75 TI 5.0X150MM CLOSED MAS | In distribution |
| 14-586545CL | 4.5/5.5X450MM COCR LOW ROD | In distribution |
| 14-582660 | 4.75 TI 7.0X60MM MAS | In distribution |
| 14-583933 | 4.75 TI 9.5X115MM CLOSED MAS | In distribution |
| 14-582640 | 4.75 TI 7.0X40MM MAS | In distribution |
| 14-583525 | 4.75 TI 6.5X25MM CLOSED MAS | In distribution |
| 14-583451 | 4.75 TI 6.0X135MM CLOSED MAS | In distribution |
| 14-582130 | 4.75 TI 4.5X30MM MAS | In distribution |
| 14-583841 | 4.75 TI 8.5X125MM CLOSED MAS | In distribution |
| 14-582256 | 4.75 TI 5.0X140MM MAS | In distribution |
| 14-586530CH | 4.5/5.5X300MM COCR HIGH ROD | In distribution |
| 14-584856 | 4.75 TI 8.5X140MM FIXED SCREW | In distribution |
| 14-583940 | 4.75 TI 9.5X40MM CLOSED MAS | In distribution |
| 14-583965 | 4.75 TI 9.5X65MM CLOSED MAS | In distribution |
| 14-584635 | 4.75 TI 7.0X35MM FIXED SCREW | In distribution |
| 14-582525 | 4.75 TI 6.5X25MM MAS | In distribution |
| 14-584851 | 4.75 TI 8.5X135MM FIXED SCREW | In distribution |
| 14-585360CS | 4.5X600MM COCR STD LS CRV ROD | In distribution |
| 14-582929 | 4.75 TI 9.5X110MM MAS | In distribution |
| 14-584585 | 4.75 TI 6.5X85MM FIXED SCREW | In distribution |
| 14-583545 | 4.75 TI 6.5X45MM CLOSED MAS | In distribution |
| 14-587360CS | 4.75X600MM COCR STD LS CRV ROD | In distribution |
| 14-584826 | 4.75 TI 8.5X110MM FIXED SCREW | In distribution |
| 14-584346 | 4.75 TI 5.5X130MM FIXED SCREW | In distribution |
| 14-581675R | 4.75 TI 7.5MM RT OFFSET HOOK | In distribution |
| 14-587113CS | 4.75X130MM COCR STD HEX ROD | In distribution |
| 14-581530 | 4.75 TI SMALL REDUC LAM HOOK | In distribution |
| 14-588530CL | 4.75/5.5X300MM COCR LOW ROD | In distribution |
| 14-584156 | 4.75 TI 4.5X140MM FIXED SCREW | In distribution |
| 14-582222 | 4.75 TI 5.0X22.5MM MAS | In distribution |
| 14-584455 | 4.75 TI 6.0X55MM FIXED SCREW | In distribution |
| 14-582495 | 4.75 TI 6.0X95MM MAS | In distribution |
| 14-582740 | 4.75 TI 7.5X40MM MAS | In distribution |
| 14-583766 | 4.75 TI 7.5X150MM CLOSED MAS | In distribution |
| 14-583475 | 4.75 TI 6.0X75MM CLOSED MAS | In distribution |
| 14-583799 | 4.75 TI 7.5X100MM CLOSED MAS | In distribution |
| 14-583953 | 4.75 TI 9.5X135MM CLOSED MAS | In distribution |
| 14-588560CL | 4.75/5.5X600MM COCR LOW ROD | In distribution |
| 14-582356 | 4.75 TI 5.5X140MM MAS | In distribution |
| 14-585103CH | 4.5X30MM COCR HIGH HEX ROD | In distribution |
| 14-583261 | 4.75 TI 5.0X145MM CLOSED MAS | In distribution |
| 14-583621 | 4.75 TI 7.0X105MM CLOSED MAS | In distribution |
| 14-581290L | 4.75 TI 9MM LEFT ANGLED HOOK | In distribution |
| 14-583948 | 4.75 TI 10.5X130MM CLOSED MAS | In distribution |
| 14-583230 | 4.75 TI 5.0X30MM CLOSED MAS | In distribution |
| 14-583546 | 4.75 TI 6.5X130MM CLOSED MAS | In distribution |
| 14-585103T | 4.5X30MM TI ALLOY HEX ROD | In distribution |
| 14-584650 | 4.75 TI 7.0X50MM FIXED SCREW | In distribution |
| 14-584020 | 4.75 TI 4.0X20MM FIXED SCREW | In distribution |
| 14-585213CH | 4.5X130MM COCR HI MR CRV ROD | In distribution |
| 14-584355 | 4.75 TI 5.5X55MM FIXED SCREW | In distribution |
| 14-584656 | 4.75 TI 7.0X140MM FIXED SCREW | In distribution |
| 14-584245 | 4.75 TI 5.0X45MM FIXED SCREW | In distribution |
| 14-585360CL | 4.5X600MM COCR LOW LS CRV ROD | In distribution |
| 14-582865 | 4.75 TI 8.5X65MM MAS | In distribution |
| 14-585251T | 4.5X510MM TI ALLOY MR CRV ROD | In distribution |
| 14-583280 | 4.75 TI 5.0X80MM CLOSED MAS | In distribution |
| 14-583195 | 4.75 TI 4.5X95MM CLOSED MAS | In distribution |
| 14-589713 | 4.75 TI OFFSET CONNECTOR, 35MM | In distribution |
| 14-582934 | 4.75 TI 10.5X115MM MAS | In distribution |
| 14-583985 | 4.75 TI 9.5X85MM CLOSED MAS | In distribution |
| 14-583331 | 4.75 TI 5.5X115MM CLOSED MAS | In distribution |
| 14-580912 | 4.75 TI 12.5MM UNIVERSAL HOOK | In distribution |
| 14-583160 | 4.75 TI 4.5X60MM CLOSED MAS | In distribution |
| 14-583670 | 4.75 TI 7.0X70MM CLOSED MAS | In distribution |
| 14-586530CL | 4.5/5.5X300MM COCR LOW ROD | In distribution |
| 14-584075 | 4.75 TI 4.0X75MM FIXED SCREW | In distribution |
| 14-589702R | 4.75 TI RIGHT OFFSET CONN, SM | In distribution |
| 14-584161 | 4.75 TI 4.5X145MM FIXED SCREW | In distribution |
| 14-584495 | 4.75 TI 6.0X95MM FIXED SCREW | In distribution |
| 14-584940 | 4.75 TI 9.5X40MM FIXED SCREW | In distribution |
| 14-581535 | 4.75 TI 3.5MM REDUC LAM HOOK | In distribution |
| 14-582963 | 4.75 TI 9.5X145MM MAS | In distribution |
| 14-583040 | 4.75 TI 4.0X40MM CLOSED MAS | In distribution |
| 14-586520CL | 4.5/5.5X200MM COCR LOW ROD | In distribution |
| 14-584920 | 4.75 TI 9.5X20MM FIXED SCREW | In distribution |
| 14-586420CH | 4.5/4.75X200MM COCR HIGH ROD | In distribution |
| 14-584655 | 4.75 TI 7.0X55MM FIXED SCREW | In distribution |
| 14-584370 | 4.75 TI 5.5X70MM FIXED SCREW | In distribution |
| 14-582631 | 4.75 TI 7.0X115MM MAS | In distribution |
| 14-584566 | 4.75 TI 6.5X150MM FIXED SCREW | In distribution |
| 14-581690R | 4.75 TI 9MM RT OFFSET HOOK | In distribution |
| 14-582345 | 4.75 TI 5.5X45MM MAS | 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.