CIMPLICITY SPINAL SYSTEM

Intervertebral Fusion Device With Bone Graft, Cervical

SPINE SMITH PARTNERS L.P.

The following data is part of a premarket notification filed by Spine Smith Partners L.p. with the FDA for Cimplicity Spinal System.

Pre-market Notification Details

Device IDK073320
510k NumberK073320
Device Name:CIMPLICITY SPINAL SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant SPINE SMITH PARTNERS L.P. 5300 NORTH LAMAR BLVD #107 Austin,  TX  78751
ContactRobert Jones
CorrespondentRobert Jones
SPINE SMITH PARTNERS L.P. 5300 NORTH LAMAR BLVD #107 Austin,  TX  78751
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-26
Decision Date2008-02-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817771020003 K073320 000

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