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

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