Curiteva Sacroiliac Joint Fusion System

Sacroiliac Joint Fixation

Curiteva, Inc.

The following data is part of a premarket notification filed by Curiteva, Inc. with the FDA for Curiteva Sacroiliac Joint Fusion System.

Pre-market Notification Details

Device IDK210402
510k NumberK210402
Device Name:Curiteva Sacroiliac Joint Fusion System
ClassificationSacroiliac Joint Fixation
Applicant Curiteva, Inc. 25127 Will McComb Drive Tanner,  AL  35671
ContactEric Linder
CorrespondentEric Linder
Curiteva, Inc. 25127 Will McComb Drive Tanner,  AL  35671
Product CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-10
Decision Date2021-09-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B648C61495SC0 K210402 000
B648C61470450 K210402 000
B648C61470400 K210402 000
B648C61470350 K210402 000
B648C61470300 K210402 000
B648C61412SC0 K210402 000
B648C61412KC0 K210402 000
B648C61412700 K210402 000
B648C61412650 K210402 000
B648C61412600 K210402 000
B648C61412550 K210402 000
B648C61412500 K210402 000
B648C61412450 K210402 000
B648C61412400 K210402 000
B648C61412350 K210402 000
B648C61470500 K210402 000
B648C61470550 K210402 000
B648C61470600 K210402 000
B648C61495KC0 K210402 000
B648C61495700 K210402 000
B648C61495650 K210402 000
B648C61495600 K210402 000
B648C61495550 K210402 000
B648C61495500 K210402 000
B648C61495450 K210402 000
B648C61495400 K210402 000
B648C61495350 K210402 000
B648C61495300 K210402 000
B648C61470SC0 K210402 000
B648C61470KC0 K210402 000
B648C61470700 K210402 000
B648C61470650 K210402 000
B648C61412300 K210402 000

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