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FDA 510(k)

CxHA PEEK Cervical IBF System

K-Number: K181115 · 2018-07-16

ApplicantInnovasis, Inc.
Decision Date2018-07-16
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CxHA PEEK Cervical IBF System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2018-07-16 under approval number K181115. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CxHA PEEK Cervical IBF System?

CxHA PEEK Cervical IBF System is a medical device that received FDA 510(k) clearance on 2018-07-16. It is manufactured by Innovasis, Inc.. The 510(k) number is K181115.

When was CxHA PEEK Cervical IBF System approved by the FDA?

CxHA PEEK Cervical IBF System received FDA 510(k) clearance on 2018-07-16, under approval number K181115.

What company makes CxHA PEEK Cervical IBF System?

CxHA PEEK Cervical IBF System is manufactured by Innovasis, Inc..

What is the FDA product code for CxHA PEEK Cervical IBF System?

The FDA product code for CxHA PEEK Cervical IBF System is ODP.

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Other Devices by Innovasis, Inc.

K162143FixxSure® X-Link K162236Ax Stand-Alone ALIF System K181063Kestrel™ Buttress Plate System K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System K192049Oryx Cervical Plate System K192354Innovasis Gibralt Spine System

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Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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