A-CIFT SoloFuse

Intervertebral Fusion Device With Integrated Fixation, Cervical

SpineFrontier, Inc.

The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for A-cift Solofuse.

Pre-market Notification Details

Device IDK172484
510k NumberK172484
Device Name:A-CIFT SoloFuse
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant SpineFrontier, Inc. 350 Main Street 3rd Floor Malden,  MA  02148
ContactVito Lore
CorrespondentMeredith L. May
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-17
Decision Date2018-05-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190361023722 K172484 000
00190361023715 K172484 000
00190361023708 K172484 000
00190361023692 K172484 000
00190361023685 K172484 000
00190361023678 K172484 000
00190361023661 K172484 000
00190361023654 K172484 000

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