SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers

Intervertebral Fusion Device With Bone Graft, Lumbar

Camber Spine Technologies, LLC

The following data is part of a premarket notification filed by Camber Spine Technologies, Llc with the FDA for Spira-t Oblique Posterior Lumbar Spacers, Spira-p Posterior Lumbar Spacers.

Pre-market Notification Details

Device IDK210595
510k NumberK210595
Device Name:SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Camber Spine Technologies, LLC 501 Allendale Road King Of Prussia,  PA  19604
ContactDonald W. Guthner
CorrespondentDonald W. Guthner
Camber Spine Technologies, LLC 501 Allendale Road King Of Prussia,  PA  19604
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-01
Decision Date2021-06-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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