Harrier-SA Lumbar Interbody System

Intervertebral Fusion Device With Bone Graft, Lumbar

ChoiceSpine LLC

The following data is part of a premarket notification filed by Choicespine Llc with the FDA for Harrier-sa Lumbar Interbody System.

Pre-market Notification Details

Device IDK191367
510k NumberK191367
Device Name:Harrier-SA Lumbar Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant ChoiceSpine LLC 400 Erin Drive Knoxville,  TN  37922
ContactKim Finch
CorrespondentKim Finch
ChoiceSpine LLC 400 Erin Drive Knoxville,  TN  37922
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-22
Decision Date2019-07-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840996184137 K191367 000
00840996184007 K191367 000
00840996183994 K191367 000
00840996183987 K191367 000
00840996183970 K191367 000
00840996183963 K191367 000
00840996192965 K191367 000
00840996192958 K191367 000
00840996192569 K191367 000
00840996192514 K191367 000
00840996184014 K191367 000
00840996184021 K191367 000
00840996184038 K191367 000
00840996184120 K191367 000
00840996184113 K191367 000
00840996184106 K191367 000
00840996184090 K191367 000
00840996184083 K191367 000
00840996184076 K191367 000
00840996184069 K191367 000
00840996184052 K191367 000
00840996184045 K191367 000
00840996182119 K191367 000

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