Admiral ACP System

Appliance, Fixation, Spinal Intervertebral Body

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Admiral Acp System.

Pre-market Notification Details

Device IDK202064
510k NumberK202064
Device Name:Admiral ACP System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactAly Alvarez
CorrespondentAly Alvarez
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-27
Decision Date2020-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889981238759 K202064 000
10889981238575 K202064 000
10889981238568 K202064 000
10889981238551 K202064 000
10889981238544 K202064 000
10889981238537 K202064 000
10889981238520 K202064 000
10889981238513 K202064 000
10889981238506 K202064 000
10889981238490 K202064 000
10889981238469 K202064 000
10889981238438 K202064 000
10889981238407 K202064 000
10889981238377 K202064 000
10889981238346 K202064 000
10889981238339 K202064 000
10889981238582 K202064 000
10889981238599 K202064 000
10889981238742 K202064 000
10889981238735 K202064 000
10889981238728 K202064 000
10889981238711 K202064 000
10889981238704 K202064 000
10889981238698 K202064 000
10889981238681 K202064 000
10889981238674 K202064 000
10889981238667 K202064 000
10889981238650 K202064 000
10889981238643 K202064 000
10889981238636 K202064 000
10889981238629 K202064 000
10889981238612 K202064 000
10889981238605 K202064 000
10889981238322 K202064 000
10889981238315 K202064 000
10889981238308 K202064 000
10889981238124 K202064 000
10889981238117 K202064 000
10889981238100 K202064 000
10889981238094 K202064 000
10889981238087 K202064 000
10889981238070 K202064 000
10889981238063 K202064 000
10889981238056 K202064 000
10889981238049 K202064 000
10889981238032 K202064 000
10889981238025 K202064 000
10889981238018 K202064 000
10889981238001 K202064 000
10889981237998 K202064 000
10889981237981 K202064 000
10889981238131 K202064 000
10889981238148 K202064 000
10889981238292 K202064 000
10889981238285 K202064 000
10889981238278 K202064 000
10889981238261 K202064 000
10889981238254 K202064 000
10889981238247 K202064 000
10889981238230 K202064 000
10889981238223 K202064 000
10889981238216 K202064 000
10889981238209 K202064 000
10889981238193 K202064 000
10889981238186 K202064 000
10889981238179 K202064 000
10889981238162 K202064 000
10889981238155 K202064 000
10889981291303 K202064 000
10889981239831 K202064 000
10889981239541 K202064 000
10889981239534 K202064 000
10889981239527 K202064 000
10889981239510 K202064 000
10889981239503 K202064 000
10889981239268 K202064 000
10889981239251 K202064 000
10889981239237 K202064 000
10889981239190 K202064 000
10889981239176 K202064 000
10889981239169 K202064 000
10889981239152 K202064 000
10889981239145 K202064 000
10889981239138 K202064 000
10889981239121 K202064 000
10889981239558 K202064 000
10889981239565 K202064 000
10889981239824 K202064 000
10889981239817 K202064 000
10889981239800 K202064 000
10889981239794 K202064 000
10889981239787 K202064 000
10889981239770 K202064 000
10889981239763 K202064 000
10889981239756 K202064 000
10889981239749 K202064 000
10889981239732 K202064 000
10889981239725 K202064 000
10889981239718 K202064 000
10889981239596 K202064 000
10889981239589 K202064 000
10889981239572 K202064 000
10889981239114 K202064 000
10889981239107 K202064 000
10889981239091 K202064 000
10889981238919 K202064 000
10889981238902 K202064 000
10889981238896 K202064 000
10889981238889 K202064 000
10889981238872 K202064 000
10889981238865 K202064 000
10889981238858 K202064 000
10889981238841 K202064 000
10889981238834 K202064 000
10889981238827 K202064 000
10889981238810 K202064 000
10889981238803 K202064 000
10889981238797 K202064 000
10889981238780 K202064 000
10889981238773 K202064 000
10889981238926 K202064 000
10889981238933 K202064 000
10889981239084 K202064 000
10889981239077 K202064 000
10889981239060 K202064 000
10889981239053 K202064 000
10889981239046 K202064 000
10889981239039 K202064 000
10889981239022 K202064 000
10889981239015 K202064 000
10889981239008 K202064 000
10889981238995 K202064 000
10889981238988 K202064 000
10889981238971 K202064 000
10889981238964 K202064 000
10889981238957 K202064 000
10889981238940 K202064 000
10889981238766 K202064 000

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