STALIF C; STALIF C-Ti

Intervertebral Fusion Device With Integrated Fixation, Cervical

Centinel Spine, Inc.

The following data is part of a premarket notification filed by Centinel Spine, Inc. with the FDA for Stalif C; Stalif C-ti.

Pre-market Notification Details

Device IDK150053
510k NumberK150053
Device Name:STALIF C; STALIF C-Ti
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant Centinel Spine, Inc. 900 Airport Road, Suite 3B West Chester,  PA  19380
ContactJohn Parry
CorrespondentJustin Eggleton
MCRA, LLC 1331 H STREET NW, 12TH FLOOR Washington,  DC  20005
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-12
Decision Date2015-06-24
Summary:summary

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