C-BOX PEEK CERVICAL IBF

Intervertebral Fusion Device With Bone Graft, Cervical

INNOVASIS, INC.

The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for C-box Peek Cervical Ibf.

Pre-market Notification Details

Device IDK132991
510k NumberK132991
Device Name:C-BOX PEEK CERVICAL IBF
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City,  UT  84107
ContactMarshall Mccarty
CorrespondentMarshall Mccarty
INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City,  UT  84107
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-24
Decision Date2014-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M71112512130 K132991 000
M71112511130 K132991 000
M71112510130 K132991 000
M71112509130 K132991 000
M71112508130 K132991 000
M71112507130 K132991 000
M71112506130 K132991 000

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