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FDA 510(k)

HAcancellous PEEK-C Porous HA PEEK Cervical IBF System

K-Number: K220875 · 2022-08-26

ApplicantInnovasis, Inc.
Decision Date2022-08-26
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HAcancellous PEEK-C Porous HA PEEK Cervical IBF System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2022-08-26 under approval number K220875. 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 HAcancellous PEEK-C Porous HA PEEK Cervical IBF System?

HAcancellous PEEK-C Porous HA PEEK Cervical IBF System is a medical device that received FDA 510(k) clearance on 2022-08-26. It is manufactured by Innovasis, Inc.. The 510(k) number is K220875.

When was HAcancellous PEEK-C Porous HA PEEK Cervical IBF System approved by the FDA?

HAcancellous PEEK-C Porous HA PEEK Cervical IBF System received FDA 510(k) clearance on 2022-08-26, under approval number K220875.

What company makes HAcancellous PEEK-C Porous HA PEEK Cervical IBF System?

HAcancellous PEEK-C Porous HA PEEK Cervical IBF System is manufactured by Innovasis, Inc..

What is the FDA product code for HAcancellous PEEK-C Porous HA PEEK Cervical IBF System?

The FDA product code for HAcancellous PEEK-C Porous HA PEEK Cervical IBF System is ODP.

Related Clinical Trials

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Other Devices by Innovasis, Inc.

K162143FixxSure® X-Link K162236Ax Stand-Alone ALIF System K181115CxHA PEEK Cervical IBF System K181063Kestrel™ Buttress Plate System K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System K192049Oryx Cervical Plate 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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