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510(k) K201793

EDEN Peek Cage by Jmt Co., Ltd. — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2021
Date Received
June 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Jmt Co., Ltd.

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  • K201788 — EDEN Spinal Fixation System (June 23, 2022)

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