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FDA 510(k)

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

K-Number: K212038 · 2021-08-27

ApplicantK&J Consulting Corporation
Decision Date2021-08-27
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is a medical device manufactured by K&J Consulting Corporation. It received FDA 510(k) clearance on 2021-08-27 under approval number K212038. 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 K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by K&J Consulting Corporation. The 510(k) number is K212038.

When was K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage approved by the FDA?

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage received FDA 510(k) clearance on 2021-08-27, under approval number K212038.

What company makes K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is manufactured by K&J Consulting Corporation.

What is the FDA product code for K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

The FDA product code for K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is ODP.

Other Devices by K&J Consulting Corporation

K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System

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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