FOCUS Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Nvision Biomedical Technologies, LLC

The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Focus Pedicle Screw System.

Pre-market Notification Details

Device IDK180458
510k NumberK180458
Device Name:FOCUS Pedicle Screw System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Nvision Biomedical Technologies, LLC 1350 N Loop 1604 E, Suite 103 San Antonio,  TX  78232
ContactDiana Langham
CorrespondentAllison C. Komiyama
AcKnowledge Regulatory Strategies, LLC 2934 Hawthorn St. San Diego,  CA  92104
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-20
Decision Date2018-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814008027521 K180458 000
00814008027408 K180458 000
00814008027392 K180458 000
00814008027385 K180458 000
00814008027378 K180458 000
00814008027361 K180458 000
00814008027354 K180458 000
00814008027347 K180458 000
00814008027330 K180458 000
00814008027323 K180458 000
00814008027415 K180458 000
00814008027422 K180458 000
00814008027514 K180458 000
00814008027507 K180458 000
00814008027491 K180458 000
00814008027484 K180458 000
00814008027477 K180458 000
00814008027460 K180458 000
00814008027453 K180458 000
00814008027446 K180458 000
00814008027439 K180458 000
00814008027316 K180458 000
00814008027309 K180458 000
00814008027187 K180458 000
00814008027170 K180458 000
00814008027163 K180458 000
00814008027156 K180458 000
00814008027149 K180458 000
00814008027132 K180458 000
00814008027125 K180458 000
00814008027118 K180458 000
00814008027101 K180458 000
00814008027194 K180458 000
00814008027200 K180458 000
00814008027293 K180458 000
00814008027286 K180458 000
00814008027279 K180458 000
00814008027262 K180458 000
00814008027255 K180458 000
00814008027248 K180458 000
00814008027231 K180458 000
00814008027224 K180458 000
00814008027217 K180458 000
00814008027095 K180458 000
00814008027965 K180458 000
00814008027842 K180458 000
00814008027835 K180458 000
00814008027828 K180458 000
00814008027811 K180458 000
00814008027804 K180458 000
00814008027798 K180458 000
00814008027781 K180458 000
00814008027774 K180458 000
00814008027767 K180458 000
00814008027859 K180458 000
00814008027866 K180458 000
00814008027958 K180458 000
00814008027941 K180458 000
00814008027934 K180458 000
00814008027927 K180458 000
00814008027910 K180458 000
00814008027903 K180458 000
00814008027897 K180458 000
00814008027880 K180458 000
00814008027873 K180458 000
00814008027750 K180458 000
00814008027743 K180458 000
00814008027620 K180458 000
00814008027613 K180458 000
00814008027606 K180458 000
00814008027590 K180458 000
00814008027583 K180458 000
00814008027576 K180458 000
00814008027569 K180458 000
00814008027552 K180458 000
00814008027545 K180458 000
00814008027637 K180458 000
00814008027644 K180458 000
00814008027736 K180458 000
00814008027729 K180458 000
00814008027712 K180458 000
00814008027705 K180458 000
00814008027699 K180458 000
00814008027682 K180458 000
00814008027675 K180458 000
00814008027668 K180458 000
00814008027651 K180458 000
00814008027538 K180458 000
00814008027088 K180458 000
00814008026630 K180458 000
00814008026517 K180458 000
00814008026500 K180458 000
00814008026494 K180458 000
00814008026487 K180458 000
00814008026470 K180458 000
00814008026463 K180458 000
00814008026456 K180458 000
00814008026449 K180458 000
00814008026432 K180458 000
00814008026524 K180458 000
00814008026531 K180458 000
00814008026623 K180458 000
00814008026616 K180458 000
00814008026609 K180458 000
00814008026593 K180458 000
00814008026586 K180458 000
00814008026579 K180458 000
00814008026562 K180458 000
00814008026555 K180458 000
00814008026548 K180458 000
00814008026425 K180458 000
00814008026418 K180458 000
00814008026296 K180458 000
00814008026272 K180458 000
00814008026241 K180458 000
00814008026234 K180458 000
00814008026203 K180458 000
00814008026197 K180458 000
00814008026180 K180458 000
00814008026173 K180458 000
00814008025831 K180458 000
00814008026302 K180458 000
00814008026319 K180458 000
00814008026401 K180458 000
00814008026395 K180458 000
00814008026388 K180458 000
00814008026371 K180458 000
00814008026364 K180458 000
00814008026357 K180458 000
00814008026340 K180458 000
00814008026333 K180458 000
00814008026326 K180458 000
00810005667241 K180458 000
00814008027071 K180458 000
00814008026951 K180458 000
00814008026944 K180458 000
00814008026937 K180458 000
00814008026920 K180458 000
00814008026913 K180458 000
00814008026906 K180458 000
00814008026890 K180458 000
00814008026883 K180458 000
00814008026876 K180458 000
00814008026968 K180458 000
00814008026975 K180458 000
00814008027064 K180458 000
00814008027057 K180458 000
00814008027040 K180458 000
00814008027033 K180458 000
00814008027026 K180458 000
00814008027019 K180458 000
00814008027002 K180458 000
00814008026999 K180458 000
00814008026982 K180458 000
00814008026869 K180458 000
00814008026852 K180458 000
00814008026739 K180458 000
00814008026722 K180458 000
00814008026715 K180458 000
00814008026708 K180458 000
00814008026692 K180458 000
00814008026685 K180458 000
00814008026678 K180458 000
00814008026661 K180458 000
00814008026654 K180458 000
00814008026746 K180458 000
00814008026753 K180458 000
00814008026845 K180458 000
00814008026838 K180458 000
00814008026821 K180458 000
00814008026814 K180458 000
00814008026807 K180458 000
00814008026791 K180458 000
00814008026784 K180458 000
00814008026777 K180458 000
00814008026760 K180458 000
00814008026647 K180458 000
00814008029297 K180458 000
00814008029174 K180458 000
00814008029167 K180458 000
00814008029150 K180458 000
00814008029143 K180458 000
00814008029136 K180458 000
00814008029129 K180458 000
00814008029112 K180458 000
00814008029105 K180458 000
00814008029099 K180458 000
00814008029181 K180458 000
00814008029198 K180458 000
00814008029280 K180458 000
00814008029273 K180458 000
00814008029266 K180458 000
00814008029259 K180458 000
00814008029242 K180458 000
00814008029235 K180458 000
00814008029228 K180458 000
00814008029211 K180458 000
00814008029204 K180458 000
00814008029082 K180458 000
00814008029075 K180458 000
00814008028955 K180458 000
00814008028948 K180458 000
00814008028931 K180458 000
00814008028924 K180458 000
00814008028917 K180458 000
00814008028900 K180458 000
00814008028894 K180458 000
00814008028887 K180458 000
00814008028870 K180458 000
00814008028962 K180458 000
00814008028979 K180458 000
00814008029068 K180458 000
00814008029051 K180458 000
00814008029044 K180458 000
00814008029037 K180458 000
00814008029020 K180458 000
00814008029013 K180458 000
00814008029006 K180458 000
00814008028993 K180458 000
00814008028986 K180458 000
00814008028863 K180458 000
00814008029730 K180458 000
00814008029617 K180458 000
00814008029600 K180458 000
00814008029594 K180458 000
00814008029587 K180458 000
00814008029570 K180458 000
00814008029563 K180458 000
00814008029556 K180458 000
00814008029549 K180458 000
00814008029532 K180458 000
00814008029624 K180458 000
00814008029631 K180458 000
00814008029723 K180458 000
00814008029716 K180458 000
00814008029709 K180458 000
00814008029693 K180458 000
00814008029686 K180458 000
00814008029679 K180458 000
00814008029662 K180458 000
00814008029655 K180458 000
00814008029648 K180458 000
00814008029525 K180458 000
00814008029518 K180458 000
00814008029396 K180458 000
00814008029389 K180458 000
00814008029372 K180458 000
00814008029365 K180458 000
00814008029358 K180458 000
00814008029341 K180458 000
00814008029334 K180458 000
00814008029327 K180458 000
00814008029310 K180458 000
00814008029402 K180458 000
00814008029419 K180458 000
00814008029501 K180458 000
00814008029495 K180458 000
00814008029488 K180458 000
00814008029471 K180458 000
00814008029464 K180458 000
00814008029457 K180458 000
00814008029440 K180458 000
00814008029433 K180458 000
00814008029426 K180458 000
00814008029303 K180458 000
00814008028856 K180458 000
00814008028405 K180458 000
00814008028283 K180458 000
00814008028276 K180458 000
00814008028269 K180458 000
00814008028252 K180458 000
00814008028245 K180458 000
00814008028238 K180458 000
00814008028221 K180458 000
00814008028214 K180458 000
00814008028207 K180458 000
00814008028290 K180458 000
00814008028306 K180458 000
00814008028399 K180458 000
00814008028382 K180458 000
00814008028375 K180458 000
00814008028368 K180458 000
00814008028351 K180458 000
00814008028344 K180458 000
00814008028337 K180458 000
00814008028320 K180458 000
00814008028313 K180458 000
00814008028191 K180458 000
00814008028184 K180458 000
00814008028061 K180458 000
00814008028054 K180458 000
00814008028047 K180458 000
00814008028030 K180458 000
00814008028023 K180458 000
00814008028016 K180458 000
00814008028009 K180458 000
00814008027996 K180458 000
00814008027989 K180458 000
00814008028078 K180458 000
00814008028085 K180458 000
00814008028177 K180458 000
00814008028160 K180458 000
00814008028153 K180458 000
00814008028146 K180458 000
00814008028139 K180458 000
00814008028122 K180458 000
00814008028115 K180458 000
00814008028108 K180458 000
00814008028092 K180458 000
00814008027972 K180458 000
00814008028849 K180458 000
00814008028726 K180458 000
00814008028719 K180458 000
00814008028702 K180458 000
00814008028696 K180458 000
00814008028689 K180458 000
00814008028672 K180458 000
00814008028665 K180458 000
00814008028658 K180458 000
00814008028641 K180458 000
00814008028733 K180458 000
00814008028740 K180458 000
00814008028832 K180458 000
00814008028825 K180458 000
00814008028818 K180458 000
00814008028801 K180458 000
00814008028795 K180458 000
00814008028788 K180458 000
00814008028771 K180458 000
00814008028764 K180458 000
00814008028757 K180458 000
00814008028634 K180458 000
00814008028627 K180458 000
00814008028504 K180458 000
00814008028498 K180458 000
00814008028481 K180458 000
00814008028474 K180458 000
00814008028467 K180458 000
00814008028450 K180458 000
00814008028443 K180458 000
00814008028436 K180458 000
00814008028429 K180458 000
00814008028511 K180458 000
00814008028528 K180458 000
00814008028610 K180458 000
00814008028603 K180458 000
00814008028597 K180458 000
00814008028580 K180458 000
00814008028573 K180458 000
00814008028566 K180458 000
00814008028559 K180458 000
00814008028542 K180458 000
00814008028535 K180458 000
00814008028412 K180458 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.