HAcancellous PEEK-C Porous HA PEEK Cervical IBF System

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 Hacancellous Peek-c Porous Ha Peek Cervical Ibf System.

Pre-market Notification Details

Device IDK220875
510k NumberK220875
Device Name:HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Innovasis, Inc. 614 E 3900 S Salt Lake City,  UT  84107
ContactMarshall McCarty
CorrespondentMarshall McCarty
Innovasis, Inc. 614 E 3900 S Salt Lake City,  UT  84107
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-25
Decision Date2022-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M711591315070 K220875 000
M711591417111 K220875 000
M711591517061 K220875 000
M711591517071 K220875 000
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M711591618081 K220875 000
M711591417101 K220875 000
M711591417091 K220875 000
M711591417081 K220875 000
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M711591315091 K220875 000
M711591315101 K220875 000
M711591315121 K220875 000
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M711591416111 K220875 000
M711591416121 K220875 000
M711591417061 K220875 000
M711591417071 K220875 000
M711591618091 K220875 000
M711591618101 K220875 000
M711591214081 K220875 000
M711591214091 K220875 000
M711591214101 K220875 000
M711591214111 K220875 000
M711591214121 K220875 000
M711591215061 K220875 000
M711591215071 K220875 000
M711591215081 K220875 000
M711591215091 K220875 000
M711591215101 K220875 000
M711591215111 K220875 000
M711591214071 K220875 000
M711591214060 K220875 000
M711591619111 K220875 000
M711591618111 K220875 000
M711591618121 K220875 000
M711591619061 K220875 000
M711591315061 K220875 000
M711591315111 K220875 000
M711591416061 K220875 000
M711591416071 K220875 000
M711591619071 K220875 000
M711591619081 K220875 000
M711591619091 K220875 000
M711591619101 K220875 000
M711591215121 K220875 000

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