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FDA 510(k)

EDEN Peek Cage

K-Number: K201793 · 2021-09-13

ApplicantJmt Co., Ltd.
Decision Date2021-09-13
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EDEN Peek Cage is a medical device manufactured by Jmt Co., Ltd.. It received FDA 510(k) clearance on 2021-09-13 under approval number K201793. 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 EDEN Peek Cage?

EDEN Peek Cage is a medical device that received FDA 510(k) clearance on 2021-09-13. It is manufactured by Jmt Co., Ltd.. The 510(k) number is K201793.

When was EDEN Peek Cage approved by the FDA?

EDEN Peek Cage received FDA 510(k) clearance on 2021-09-13, under approval number K201793.

What company makes EDEN Peek Cage?

EDEN Peek Cage is manufactured by Jmt Co., Ltd..

What is the FDA product code for EDEN Peek Cage?

The FDA product code for EDEN Peek Cage is ODP.

Other Devices by Jmt Co., Ltd.

K201788EDEN Spinal Fixation System K230762EDEN Spinal Fixation MIS System K241410EDEN ControlCath

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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