Polaris 4.75 TI Spinal System
265 catalogue numbers from 14-587151T, listed by Biomet Spine, United States, under Thoracolumbosacral Pedicle Screw System. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
265catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| 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 |
|---|---|---|
| 14-587151T | 4.75X510MM TI ALLOY HEX ROD | In distribution |
| 14-587130T | 4.75X300MM TI ALLOY HEX ROD | In distribution |
| 14-586560CL | 4.5/5.5X600MM COCR LOW ROD | In distribution |
| 14-582726 | 4.75 TI 7.5X110MM MAS | In distribution |
| 14-583130 | 4.75 TI 4.5X30MM CLOSED MAS | In distribution |
| 14-585251CS | 4.5X510MM COCR STD MR CRV ROD | In distribution |
| 14-583260 | 4.75 TI 5.0X60MM CLOSED MAS | In distribution |
| 14-584831 | 4.75 TI 8.5X115MM FIXED SCREW | In distribution |
| 14-587213CS | 4.75X130MM COCR STD MR CRV ROD | In distribution |
| 14-583741 | 4.75 TI 7.5X125MM CLOSED MAS | In distribution |
| 14-585151CH | 4.5X510MM COCR HIGH HEX ROD | In distribution |
| 14-582430 | 4.75 TI 6.0X30MM MAS | In distribution |
| 14-584175 | 4.75 TI 4.5X75MM FIXED SCREW | In distribution |
| 14-586420CS | 4.5/4.75X200MM COCR STD ROD | In distribution |
| 14-584922 | 4.75 TI 9.5X22.5MM FIXED SCREW | In distribution |
| 14-583860 | 4.75 TI 8.5X60MM CLOSED MAS | In distribution |
| 14-584954 | 4.75 TI 10.5X135MM FIXED SCREW | In distribution |
| 14-584990 | 4.75 TI 9.5X90MM FIXED SCREW | In distribution |
| 14-584725 | 4.75 TI 7.5X25MM FIXED SCREW | In distribution |
| 14-583645 | 4.75 TI 7.0X45MM CLOSED MAS | In distribution |
| 14-583934 | 4.75 TI 10.5X115MM CLOSED MAS | In distribution |
| 14-581245R | 4.75 TI MEDIUM RT ANG HOOK | In distribution |
| 14-583256 | 4.75 TI 5.0X140MM CLOSED MAS | In distribution |
| 14-585113CL | 4.5X130MM COCR LOW HEX ROD | In distribution |
| 14-587213T | 4.75X130MM TI ALLOY MR CRV ROD | In distribution |
| 14-582260 | 4.75 TI 5.0X60MM MAS | In distribution |
| 14-587230T | 4.75X300MM TI ALLOY MR CRV ROD | In distribution |
| 14-583356 | 4.75 TI 5.5X140MM CLOSED MAS | In distribution |
| 14-582622 | 4.75 TI 7.0X22.5MM MAS | In distribution |
| 14-584626 | 4.75 TI 7.0X110MM FIXED SCREW | In distribution |
| 14-584630 | 4.75 TI 7.0X30MM FIXED SCREW | In distribution |
| 14-587130CL | 4.75X300MM COCR LOW HEX ROD | In distribution |
| 14-582641 | 4.75 TI 7.0X125MM MAS | In distribution |
| 14-587213CH | 4.75X130MM COCR HI MR CRV ROD | In distribution |
| 14-584827 | 4.75 TI 8.5X27.5MM FIXED SCREW | In distribution |
| 14-585230CS | 4.5X300MM COCR STD MR CRV ROD | In distribution |
| 14-580916N | 4.75 TI 16MM UNIV HK NO SPIKE | In distribution |
| 14-582126 | 4.75 TI 4.5X110MM MAS | In distribution |
| 14-582540 | 4.75 TI 6.5X40MM MAS | In distribution |
| 14-584766 | 4.75 TI 7.5X150MM FIXED SCREW | In distribution |
| 14-584475 | 4.75 TI 6.0X75MM FIXED SCREW | In distribution |
| 14-582521 | 4.75 TI 6.5X105MM MAS | In distribution |
| 14-587360T | 4.75X600MM TI ALLOY LS CRV ROD | In distribution |
| 14-583420 | 4.75 TI 6.0X20MM CLOSED MAS | In distribution |
| 14-581130 | 4.75 TI SMALL PEDICLE HOOK | In distribution |
| 14-584866 | 4.75 TI 8.5X150MM FIXED SCREW | In distribution |
| 14-583126 | 4.75 TI 4.5X110MM CLOSED MAS | In distribution |
| 14-582246 | 4.75 TI 5.0X130MM MAS | In distribution |
| 14-583731 | 4.75 TI 7.5X115MM CLOSED MAS | In distribution |
| 14-584955 | 4.75 TI 9.5X55MM FIXED SCREW | In distribution |
| 14-581675L | 4.75 TI 7.5MM LEFT OFFSET HOOK | In distribution |
| 14-585345CS | 4.5X450MM COCR STD LS CRV ROD | In distribution |
| 14-583725 | 4.75 TI 7.5X25MM CLOSED MAS | In distribution |
| 14-583636 | 4.75 TI 7.0X120MM CLOSED MAS | In distribution |
| 14-584222 | 4.75 TI 5.0X22.5MM FIXED SCREW | In distribution |
| 14-582165 | 4.75 TI 4.5X65MM MAS | In distribution |
| 14-581160 | 4.75 TI LARGE PEDICLE HOOK | In distribution |
| 14-584726 | 4.75 TI 7.5X110MM FIXED SCREW | In distribution |
| 14-583565 | 4.75 TI 6.5X65MM CLOSED MAS | In distribution |
| 14-586460T | 4.5/4.75X600MM TI ALLOY ROD | In distribution |
| 14-584981 | 4.75 TI 10.5X80MM FIXED SCREW | In distribution |
| 14-583345 | 4.75 TI 5.5X45MM CLOSED MAS | In distribution |
| 14-589750 | 4.75 TI 50MM LAT CONN | In distribution |
| 14-582451 | 4.75 TI 6.0X135MM MAS | In distribution |
| 14-586520CS | 4.5/5.5X200MM COCR STD ROD | In distribution |
| 14-581140 | 4.75 TI 4MM PEDICLE HOOK | In distribution |
| 14-584025 | 4.75 TI 4.0X25MM FIXED SCREW | In distribution |
| 14-582720 | 4.75 TI 7.5X20MM MAS | In distribution |
| 14-584422 | 4.75 TI 6.0X22.5MM FIXED SCREW | In distribution |
| 14-583241 | 4.75 TI 5.0X125MM CLOSED MAS | In distribution |
| 14-581645R | 4.75 TI MED RT OFFSET HOOK | In distribution |
| 14-583190 | 4.75 TI 4.5X90MM CLOSED MAS | In distribution |
| 14-582331 | 4.75 TI 5.5X115MM MAS | In distribution |
| 14-582460 | 4.75 TI 6.0X60MM MAS | In distribution |
| 14-586445CL | 4.5/4.75X450MM COCR LOW ROD | In distribution |
| 14-581150 | 4.75 TI 5MM PEDICLE HOOK | In distribution |
| 14-584127 | 4.75 TI 4.5X27.5MM FIXED SCREW | In distribution |
| 14-582127 | 4.75 TI 4.5X27.5MM MAS | In distribution |
| 14-586420T | 4.5/4.75X200MM TI ALLOY ROD | In distribution |
| 14-580911 | 4.75 TI 11MM UNIVERSAL HOOK | In distribution |
| 14-585260CS | 4.5X600MM COCR STD MR CRV ROD | In distribution |
| 14-589674 | 4.75 TI OPEN DOMINO, 4.75/4.75 | In distribution |
| 14-582635 | 4.75 TI 7.0X35MM MAS | In distribution |
| 14-582970 | 4.75 TI 9.5X70MM MAS | In distribution |
| 14-585145T | 4.5X450MM TI ALLOY HEX ROD | In distribution |
| 14-584927 | 4.75 TI 9.5X27.5MM FIXED SCREW | In distribution |
| 14-581860 | 4.75 TI LARGE EXTENDED HOOK | In distribution |
| 14-583045 | 4.75 TI 4.0X45MM CLOSED MAS | In distribution |
| 14-581760 | 4.75 TI LARGE ANG BLADE HOOK | In distribution |
| 14-584165 | 4.75 TI 4.5X65MM FIXED SCREW | In distribution |
| 14-580904N | 4.75 TI 4.5MM UNIV HK NO SPIKE | In distribution |
| 14-584890 | 4.75 TI 8.5X90MM FIXED SCREW | In distribution |
| 14-582850 | 4.75 TI 8.5X50MM MAS | In distribution |
| 14-587245CS | 4.75X450MM COCR STD MR CRV ROD | In distribution |
| 14-582022 | 4.75 TI 4.0X22.5MM MAS | In distribution |
| 14-582555 | 4.75 TI 6.5X55MM MAS | In distribution |
| 14-584951 | 4.75 TI 10.5X50MM FIXED SCREW | In distribution |
| 14-583550 | 4.75 TI 6.5X50MM CLOSED MAS | In distribution |
| 14-584150 | 4.75 TI 4.5X50MM FIXED SCREW | In distribution |
| 14-581050 | 4.75 TI 5MM MIDSTEM HOOK | In distribution |
| 14-583971 | 4.75 TI 10.5X70MM CLOSED MAS | In distribution |
| 14-585130T | 4.5X300MM TI ALLOY HEX ROD | In distribution |
| 14-582290 | 4.75 TI 5.0X90MM MAS | In distribution |
| 14-583490 | 4.75 TI 6.0X90MM CLOSED MAS | In distribution |
| 14-582365 | 4.75 TI 5.5X65MM MAS | In distribution |
| 14-583221 | 4.75 TI 5.0X105MM CLOSED MAS | In distribution |
| 14-582441 | 4.75 TI 6.0X125MM MAS | In distribution |
| 14-584941 | 4.75 TI 10.5X40MM FIXED SCREW | In distribution |
| 14-582270 | 4.75 TI 5.0X70MM MAS | In distribution |
| 14-582940 | 4.75 TI 9.5X40MM MAS | In distribution |
| 14-583699 | 4.75 TI 7.0X100MM CLOSED MAS | In distribution |
| 14-583831 | 4.75 TI 8.5X115MM CLOSED MAS | In distribution |
| 14-582866 | 4.75 TI 8.5X150MM MAS | In distribution |
| 14-582425 | 4.75 TI 6.0X25MM MAS | In distribution |
| 14-583780 | 4.75 TI 7.5X80MM CLOSED MAS | In distribution |
| 14-584780 | 4.75 TI 7.5X80MM FIXED SCREW | In distribution |
| 14-584380 | 4.75 TI 5.5X80MM FIXED SCREW | In distribution |
| 14-582939 | 4.75 TI 10.5X110MM MAS | In distribution |
| 14-585330CL | 4.5X300MM COCR LOW LS CRV ROD | In distribution |
| 14-582990 | 4.75 TI 9.5X90MM MAS | In distribution |
| 14-583840 | 4.75 TI 8.5X40MM CLOSED MAS | In distribution |
| 14-584535 | 4.75 TI 6.5X35MM FIXED SCREW | In distribution |
| 14-583361 | 4.75 TI 5.5X145MM CLOSED MAS | In distribution |
| 14-585160T | 4.5X600MM TI ALLOY HEX ROD | In distribution |
| 14-582998 | 4.75 TI 10.5X100MM MAS | In distribution |
| 14-584575 | 4.75 TI 6.5X75MM FIXED SCREW | In distribution |
| 14-584485 | 4.75 TI 6.0X85MM FIXED SCREW | In distribution |
| 14-589850 | 4.75 TI 50MM BRIDGE CONN | In distribution |
| 14-583366 | 4.75 TI 5.5X150MM CLOSED MAS | In distribution |
| 14-589522 | 4.75 TI 22MM FIXED CROSS CONN | In distribution |
| 14-582968 | 4.75 TI 10.5X150MM MAS | In distribution |
| 14-582141 | 4.75 TI 4.5X125MM MAS | In distribution |
| 14-582930 | 4.75 TI 9.5X30MM MAS | In distribution |
| 14-589524 | 4.75 TI 24MM FIXED CROSS CONN | In distribution |
| 14-586545CS | 4.5/5.5X450MM COCR STD ROD | In distribution |
| 14-582751 | 4.75 TI 7.5X135MM MAS | In distribution |
| 14-584998 | 4.75 TI 10.5X100MM FIXED SCREW | In distribution |
| 14-583790 | 4.75 TI 7.5X90MM CLOSED MAS | In distribution |
| 14-584327 | 4.75 TI 5.5X27.5MM FIXED SCREW | In distribution |
| 14-583925 | 4.75 TI 9.5X25MM CLOSED MAS | In distribution |
| 14-582427 | 4.75 TI 6.0X27.5MM MAS | In distribution |
| 14-582760 | 4.75 TI 7.5X60MM MAS | In distribution |
| 14-583499 | 4.75 TI 6.0X100MM CLOSED MAS | In distribution |
| 14-582651 | 4.75 TI 7.0X135MM MAS | In distribution |
| 14-584570 | 4.75 TI 6.5X70MM FIXED SCREW | In distribution |
| 14-581635R | 4.75 TI 3.5MM RT OFFSET HOOK | In distribution |
| 14-584695 | 4.75 TI 7.0X95MM FIXED SCREW | In distribution |
| 14-584545 | 4.75 TI 6.5X45MM FIXED SCREW | In distribution |
| 14-584555 | 4.75 TI 6.5X55MM FIXED SCREW | In distribution |
| 14-583640 | 4.75 TI 7.0X40MM CLOSED MAS | In distribution |
| 14-581745 | 4.75 TI MEDIUM ANG BLADE HOOK | In distribution |
| 14-581290R | 4.75 TI 9MM RIGHT ANGLED HOOK | In distribution |
| 14-585351CS | 4.5X510MM COCR STD LS CRV ROD | In distribution |
| 14-586451CL | 4.5/4.75X510MM COCR LOW ROD | In distribution |
| 14-587160CH | 4.75X600MM COCR HIGH HEX ROD | In distribution |
| 14-584435 | 4.75 TI 6.0X35MM FIXED SCREW | In distribution |
| 14-582570 | 4.75 TI 6.5X70MM MAS | In distribution |
| 14-584936 | 4.75 TI 10.5X35MM FIXED SCREW | In distribution |
| 14-583590 | 4.75 TI 6.5X90MM CLOSED MAS | In distribution |
| 14-587113CL | 4.75X130MM COCR LOW HEX ROD | In distribution |
| 14-582390 | 4.75 TI 5.5X90MM MAS | In distribution |
| 14-581550 | 4.75 TI 5MM REDUC LAM HOOK | In distribution |
| 14-583146 | 4.75 TI 4.5X130MM CLOSED MAS | In distribution |
| 14-589636 | 4.75 TI CLSD DOMINO, 4.75/6.35 | In distribution |
| 14-584225 | 4.75 TI 5.0X25MM FIXED SCREW | In distribution |
| 14-583540 | 4.75 TI 6.5X40MM CLOSED MAS | In distribution |
| 14-582230 | 4.75 TI 5.0X30MM MAS | In distribution |
| 14-581740 | 4.75 TI 4MM ANG BLADE HOOK | In distribution |
| 14-584265 | 4.75 TI 5.0X65MM FIXED SCREW | In distribution |
| 14-583020 | 4.75 TI 4.0X20MM CLOSED MAS | In distribution |
| 14-583090 | 4.75 TI 4.0X90MM CLOSED MAS | In distribution |
| 14-582599 | 4.75 TI 6.5X100MM MAS | In distribution |
| 14-584235 | 4.75 TI 5.0X35MM FIXED SCREW | In distribution |
| 14-584722 | 4.75 TI 7.5X22.5MM FIXED SCREW | In distribution |
| 14-589520 | 4.75 TI 20MM FIXED CROSS CONN | In distribution |
| 14-582121 | 4.75 TI 4.5X105MM MAS | In distribution |
| 14-582351 | 4.75 TI 5.5X135MM MAS | In distribution |
| 14-583775 | 4.75 TI 7.5X75MM CLOSED MAS | In distribution |
| 14-583931 | 4.75 TI 10.5X30MM CLOSED MAS | In distribution |
| 14-583061 | 4.75 TI 4.0X145MM CLOSED MAS | In distribution |
| 14-584755 | 4.75 TI 7.5X55MM FIXED SCREW | In distribution |
| 14-584080 | 4.75 TI 4.0X80MM FIXED SCREW | In distribution |
| 14-583070 | 4.75 TI 4.0X70MM CLOSED MAS | In distribution |
| 14-583395 | 4.75 TI 5.5X95MM CLOSED MAS | In distribution |
| 14-583080 | 4.75 TI 4.0X80MM CLOSED MAS | In distribution |
| 14-583660 | 4.75 TI 7.0X60MM CLOSED MAS | In distribution |
| 14-584525 | 4.75 TI 6.5X25MM FIXED SCREW | In distribution |
| 14-583835 | 4.75 TI 8.5X35MM CLOSED MAS | In distribution |
| 14-582875 | 4.75 TI 8.5X75MM MAS | In distribution |
| 14-583924 | 4.75 TI 9.5X105MM CLOSED MAS | In distribution |
| 14-584275 | 4.75 TI 5.0X75MM FIXED SCREW | In distribution |
| 14-582860 | 4.75 TI 8.5X60MM MAS | In distribution |
| 14-584991 | 4.75 TI 10.5X90MM FIXED SCREW | In distribution |
| 14-581540 | 4.75 TI 4MM REDUC LAM HOOK | In distribution |
| 14-581235R | 4.75 TI 3.5MM RT ANGLED HOOK | In distribution |
| 14-582435 | 4.75 TI 6.0X35MM MAS | In distribution |
| 14-582422 | 4.75 TI 6.0X22.5MM MAS | In distribution |
| 14-583785 | 4.75 TI 7.5X85MM CLOSED MAS | In distribution |
| 14-582670 | 4.75 TI 7.0X70MM MAS | In distribution |
| 14-580907N | 4.75 TI 6.5MM UNIV HK NO SPIKE | In distribution |
| 14-583960 | 4.75 TI 9.5X60MM CLOSED MAS | In distribution |
| 14-584250 | 4.75 TI 5.0X50MM FIXED SCREW | In distribution |
| 14-584855 | 4.75 TI 8.5X55MM FIXED SCREW | In distribution |
| 14-582885 | 4.75 TI 8.5X85MM MAS | In distribution |
| 14-583695 | 4.75 TI 7.0X95MM CLOSED MAS | In distribution |
| 14-581560 | 4.75 TI LARGE REDUC LAM HOOK | In distribution |
| 14-584699 | 4.75 TI 7.0X100MM FIXED SCREW | In distribution |
| 14-583351 | 4.75 TI 5.5X135MM CLOSED MAS | In distribution |
| 14-582937 | 4.75 TI 9.5X120MM MAS | In distribution |
| 14-583435 | 4.75 TI 6.0X35MM CLOSED MAS | In distribution |
| 14-589108 | 4.75 TI 85MM STRGT AXIAL CONN | In distribution |
| 14-580910N | 4.75TI 10.5MM UNIV HK NO SPIKE | In distribution |
| 14-583630 | 4.75 TI 7.0X30MM CLOSED MAS | In distribution |
| 14-582938 | 4.75 TI 10.5X120MM MAS | In distribution |
| 14-584627 | 4.75 TI 7.0X27.5MM FIXED SCREW | In distribution |
| 14-584180 | 4.75 TI 4.5X80MM FIXED SCREW | In distribution |
| 14-589505 | 4.75 TI XXS ANG CROSS CONN | In distribution |
| 14-589735 | 4.75 TI 35MM LAT CONN | In distribution |
| 14-583341 | 4.75 TI 5.5X125MM CLOSED MAS | In distribution |
| 14-583746 | 4.75 TI 7.5X130MM CLOSED MAS | In distribution |
| 14-583661 | 4.75 TI 7.0X145MM CLOSED MAS | In distribution |
| 14-584746 | 4.75 TI 7.5X130MM FIXED SCREW | In distribution |
| 14-584985 | 4.75 TI 9.5X85MM FIXED SCREW | In distribution |
| 14-587345CS | 4.75X450MM COCR STD LS CRV ROD | In distribution |
| 14-583227 | 4.75 TI 5.0X27.5MM CLOSED MAS | In distribution |
| 14-583285 | 4.75 TI 5.0X85MM CLOSED MAS | In distribution |
| 14-583929 | 4.75 TI 9.5X110MM CLOSED MAS | In distribution |
| 14-581830 | 4.75 TI SMALL EXTENDED HOOK | In distribution |
| 14-583722 | 4.75 TI 7.5X22.5MM CLOSED MAS | In distribution |
| 14-583890 | 4.75 TI 8.5X90MM CLOSED MAS | In distribution |
| 14-582946 | 4.75 TI 10.5X45MM MAS | In distribution |
| 14-584775 | 4.75 TI 7.5X75MM FIXED SCREW | In distribution |
| 14-584947 | 4.75 TI 9.5X130MM FIXED SCREW | In distribution |
| 14-583995 | 4.75 TI 9.5X95MM CLOSED MAS | In distribution |
| 14-582241 | 4.75 TI 5.0X125MM MAS | In distribution |
| 14-589702 | 4.75 TI OFFSET CONNECTOR, SM | In distribution |
| 14-582944 | 4.75 TI 10.5X125MM MAS | In distribution |
| 14-586445T | 4.5/4.75X450MM TI ALLOY ROD | In distribution |
| 14-584026 | 4.75 TI 4.0X110MM FIXED SCREW | In distribution |
| 14-584285 | 4.75 TI 5.0X85MM FIXED SCREW | In distribution |
| 14-584531 | 4.75 TI 6.5X115MM FIXED SCREW | In distribution |
| 14-584870 | 4.75 TI 8.5X70MM FIXED SCREW | In distribution |
| 14-584290 | 4.75 TI 5.0X90MM FIXED SCREW | In distribution |
| 14-582227 | 4.75 TI 5.0X27.5MM MAS | In distribution |
| 14-583675 | 4.75 TI 7.0X75MM CLOSED MAS | In distribution |
| 14-582741 | 4.75 TI 7.5X125MM MAS | In distribution |
| 14-582980 | 4.75 TI 9.5X80MM MAS | In distribution |
| 14-583866 | 4.75 TI 8.5X150MM CLOSED MAS | In distribution |
| 14-583943 | 4.75 TI 9.5X125MM CLOSED MAS | In distribution |
| 14-583825 | 4.75 TI 8.5X25MM CLOSED MAS | In distribution |
Showing 250 of 265 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151974 | 2015-11-13 |
| K141804 | 2014-09-25 |
| K121130 | 2012-06-15 |
| K091067 | 2009-07-14 |
| K081952 | 2008-10-07 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-03-12 | Class II | Nonconforming Material/Component | Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification. | 4,765 units | 2015-12-21 |
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.