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FDA 510(k)

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

K-Number: K212792 · 2021-09-23

ApplicantMedynus, Inc.
Decision Date2021-09-23
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is a medical device manufactured by Medynus, Inc.. It received FDA 510(k) clearance on 2021-09-23 under approval number K212792. 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 Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is a medical device that received FDA 510(k) clearance on 2021-09-23. It is manufactured by Medynus, Inc.. The 510(k) number is K212792.

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

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage received FDA 510(k) clearance on 2021-09-23, under approval number K212792.

What company makes Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is manufactured by Medynus, Inc..

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

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

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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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