SPINAL USA INTERBODY FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

SPINAL USA

The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Interbody Fusion Device.

Pre-market Notification Details

Device IDK080314
510k NumberK080314
Device Name:SPINAL USA INTERBODY FUSION DEVICE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SPINAL USA 644 LAKELAND EAST DR., STE. A Flowood,  MS  39232
ContactJeffrey Johnson
CorrespondentJeffrey Johnson
SPINAL USA 644 LAKELAND EAST DR., STE. A Flowood,  MS  39232
Product CodeMAX  
Subsequent Product CodeKWQ
Subsequent Product CodeODP
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-06
Decision Date2008-05-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815362023211 K080314 000
00840019929455 K080314 000
00840019929431 K080314 000
00840019929424 K080314 000
00840019929417 K080314 000
00840019929400 K080314 000
00840019929394 K080314 000
00840019929387 K080314 000
00840019929370 K080314 000
00840019929363 K080314 000
00840019929356 K080314 000
00840019929349 K080314 000
00840019929332 K080314 000
00840019929325 K080314 000
00840019929318 K080314 000
00840019929301 K080314 000
00840019929288 K080314 000
00840019929448 K080314 000
00815362023020 K080314 000
00815362023037 K080314 000
00815362023204 K080314 000
00815362023198 K080314 000
00815362023181 K080314 000
00815362023174 K080314 000
00815362023167 K080314 000
00815362023150 K080314 000
00815362023143 K080314 000
00815362023136 K080314 000
00815362023129 K080314 000
00815362023112 K080314 000
00815362023105 K080314 000
00815362023099 K080314 000
00815362023082 K080314 000
00815362023075 K080314 000
00815362023068 K080314 000
00815362023051 K080314 000
00815362023044 K080314 000
00840019929295 K080314 000

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