Aprevo Transforaminal IBF

Intervertebral Fusion Device With Bone Graft, Lumbar

Carlsmed, Inc.

The following data is part of a premarket notification filed by Carlsmed, Inc. with the FDA for Aprevo Transforaminal Ibf.

Pre-market Notification Details

Device IDK210542
510k NumberK210542
Device Name:Aprevo Transforaminal IBF
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Carlsmed, Inc. 4250 Executive Sq., Ste. 675 La Jolla,  CA  92037
ContactKaren Liu
CorrespondentKaren Liu
Carlsmed, Inc. 4250 Executive Sq., Ste. 675 La Jolla,  CA  92037
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-24
Decision Date2021-06-30

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