PolyLock Plating System

Plate, Fixation, Bone

Fusion Orthopedics

The following data is part of a premarket notification filed by Fusion Orthopedics with the FDA for Polylock Plating System.

Pre-market Notification Details

Device IDK211843
510k NumberK211843
Device Name:PolyLock Plating System
ClassificationPlate, Fixation, Bone
Applicant Fusion Orthopedics 4135 S Powder Road Mesa,  AZ  85212
ContactEli Jacobson
CorrespondentEli Jacobson
Fusion Orthopedics 4135 S Powder Road Mesa,  AZ  85212
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-15
Decision Date2022-03-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840124519572 K211843 000
00840124519725 K211843 000
00840124519732 K211843 000
00840124519749 K211843 000
00840124519756 K211843 000
00840124519763 K211843 000
00840124519770 K211843 000
00840124519787 K211843 000
00840124519794 K211843 000
00840124519800 K211843 000
00840124519817 K211843 000
00840124519824 K211843 000
00840124519718 K211843 000
00840124519701 K211843 000
00840124519695 K211843 000
00840124519589 K211843 000
00840124519596 K211843 000
00840124519602 K211843 000
00840124519619 K211843 000
00840124519626 K211843 000
00840124519633 K211843 000
00840124519640 K211843 000
00840124519657 K211843 000
00840124519664 K211843 000
00840124519671 K211843 000
00840124519688 K211843 000
00840124519831 K211843 000
00840124519893 K211843 000
00840124515390 K211843 000
00840124515406 K211843 000
00840124515413 K211843 000
00840124515420 K211843 000
00840124515437 K211843 000
00840124515444 K211843 000
00840124515451 K211843 000
00840124515468 K211843 000
00840124515475 K211843 000
00840124515482 K211843 000
00840124515499 K211843 000
00840124515383 K211843 000
00840124515376 K211843 000
00840124515369 K211843 000
00840124519909 K211843 000
00840124519916 K211843 000
00840124519923 K211843 000
00840124519930 K211843 000
00840124519947 K211843 000
00840124519954 K211843 000
00840124519961 K211843 000
00840124518445 K211843 000
00840124515338 K211843 000
00840124515345 K211843 000
00840124515352 K211843 000
00840124515505 K211843 000
00840124520363 K211843 000
00840124520677 K211843 000
00840124519978 K211843 000
00840124519985 K211843 000
00840124519992 K211843 000
00840124520004 K211843 000
00840124520011 K211843 000
00840124520028 K211843 000
00840124520035 K211843 000
00840124520042 K211843 000
00840124520059 K211843 000
00840124520066 K211843 000
00840124520073 K211843 000
00840124520936 K211843 000
00840124520929 K211843 000
00840124520912 K211843 000
00840124520684 K211843 000
00840124520714 K211843 000
00840124520721 K211843 000
00840124520738 K211843 000
00840124520745 K211843 000
00840124520752 K211843 000
00840124520769 K211843 000
00840124520776 K211843 000
00840124520783 K211843 000
00840124520790 K211843 000
00840124520905 K211843 000
00840124520080 K211843 000
00840124520097 K211843 000
00840124520240 K211843 000
00840124520257 K211843 000
00840124520264 K211843 000
00840124520271 K211843 000
00840124520288 K211843 000
00840124520295 K211843 000
00840124520301 K211843 000
00840124520318 K211843 000
00840124520325 K211843 000
00840124520332 K211843 000
00840124520349 K211843 000
00840124520233 K211843 000
00840124520226 K211843 000
00840124520219 K211843 000
00840124520103 K211843 000
00840124520110 K211843 000
00840124520127 K211843 000
00840124520134 K211843 000
00840124520141 K211843 000
00840124520158 K211843 000
00840124520165 K211843 000
00840124520172 K211843 000
00840124520189 K211843 000
00840124520196 K211843 000
00840124520202 K211843 000
00840124520356 K211843 000
00840124515512 K211843 000
00840124509795 K211843 000
00840124509948 K211843 000
00840124509955 K211843 000
00840124509962 K211843 000
00840124509979 K211843 000
00840124509986 K211843 000
00840124509993 K211843 000
00840124510005 K211843 000
00840124510012 K211843 000
00840124510029 K211843 000
00840124510036 K211843 000
00840124510043 K211843 000
00840124509931 K211843 000
00840124509924 K211843 000
00840124509917 K211843 000
00840124509801 K211843 000
00840124509818 K211843 000
00840124509825 K211843 000
00840124509832 K211843 000
00840124509849 K211843 000
00840124509856 K211843 000
00840124509863 K211843 000
00840124509870 K211843 000
00840124509887 K211843 000
00840124509894 K211843 000
00840124509900 K211843 000
00840124510050 K211843 000
00840124510067 K211843 000
00840124510210 K211843 000
00840124510241 K211843 000
00840124510258 K211843 000
00840124511132 K211843 000
00840124511361 K211843 000
00840124511347 K211843 000
00840124511354 K211843 000
00840124502451 K211843 000
00840124502468 K211843 000
00840124506480 K211843 000
00840124511101 K211843 000
00840124510203 K211843 000
00840124510197 K211843 000
00840124510180 K211843 000
00840124510074 K211843 000
00840124510081 K211843 000
00840124510098 K211843 000
00840124510104 K211843 000
00840124510111 K211843 000
00840124510128 K211843 000
00840124510135 K211843 000
00840124510142 K211843 000
00840124510159 K211843 000
00840124510166 K211843 000
00840124510173 K211843 000
00840124511118 K211843 000
00840124509788 K211843 000
00840124515529 K211843 000
00840124515680 K211843 000
00840124515697 K211843 000
00840124515703 K211843 000
00840124515710 K211843 000
00840124515727 K211843 000
00840124515734 K211843 000
00840124515741 K211843 000
00840124515758 K211843 000
00840124515765 K211843 000
00840124514720 K211843 000
00840124514737 K211843 000
00840124515673 K211843 000
00840124515666 K211843 000
00840124515659 K211843 000
00840124515536 K211843 000
00840124515543 K211843 000
00840124515550 K211843 000
00840124515567 K211843 000
00840124515574 K211843 000
00840124515598 K211843 000
00840124515604 K211843 000
00840124515611 K211843 000
00840124515628 K211843 000
00840124515635 K211843 000
00840124515642 K211843 000
00840124514751 K211843 000
00840124514768 K211843 000
00840124511057 K211843 000
00840124511064 K211843 000
00840124511071 K211843 000
00840124513693 K211843 000
00840124513709 K211843 000
00840124513716 K211843 000
00840124513723 K211843 000
00840124509733 K211843 000
00840124509740 K211843 000
00840124509757 K211843 000
00840124509764 K211843 000
00840124511040 K211843 000
00840124507487 K211843 000
00840124513792 K211843 000
00840124513679 K211843 000
00840124514744 K211843 000
00840124514775 K211843 000
00840124514669 K211843 000
00840124514676 K211843 000
00840124514683 K211843 000
00840124514102 K211843 000
00840124513754 K211843 000
00840124513761 K211843 000
00840124513778 K211843 000
00840124513785 K211843 000
00840124509771 K211843 000

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.