Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)

Intervertebral Fusion Device With Bone Graft, Lumbar

CHOICE SPINE, LP

The following data is part of a premarket notification filed by Choice Spine, Lp with the FDA for Choice Spine Lumbar Spacer System (sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (harrier™), Choice Spine Vertebral Body Replacement System (hawkeye™).

Pre-market Notification Details

Device IDK162103
510k NumberK162103
Device Name:Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant CHOICE SPINE, LP 400 Erin Drive Knoxville,  TN  37919
ContactKim Finch
CorrespondentKim Finch
CHOICE SPINE, LP 400 Erin Drive Knoxville,  TN  37919
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-29
Decision Date2016-11-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840996170666 K162103 000
00840996157315 K162103 000
00840996163712 K162103 000
00840996163729 K162103 000
00840996163736 K162103 000
00840996163743 K162103 000
00840996163750 K162103 000
00840996163767 K162103 000
00840996163774 K162103 000
00840996163781 K162103 000
00840996163798 K162103 000
00840996163804 K162103 000
00840996170628 K162103 000
00840996170635 K162103 000
00840996170642 K162103 000
00840996170659 K162103 000
00840996157308 K162103 000

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