IN:C2 SPINAL FIXATION SYSTEM

Intervertebral Fusion Device With Integrated Fixation, 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 In:c2 Spinal Fixation System.

Pre-market Notification Details

Device IDK122630
510k NumberK122630
Device Name:IN:C2 SPINAL FIXATION SYSTEM
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant SPINE SMITH PARTNERS L.P. 93 RED RIVER Austin,  TX  78701
ContactClifton (chris) Naivar
CorrespondentClifton (chris) Naivar
SPINE SMITH PARTNERS L.P. 93 RED RIVER Austin,  TX  78701
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-28
Decision Date2012-12-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817771029822 K122630 000
00817771029815 K122630 000
00817771027637 K122630 000

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