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510(k) K191047

ADI TiDAL Osteotomy Wedge by Additive Device, Inc. (Adi) D/B/A Restor3D — Product Code PLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2019
Date Received
April 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Wedge
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.

Other clearances by Additive Device, Inc. (Adi) D/B/A Restor3D

  • K191812 — ADI Cervical Interbody Fusion Device (October 24, 2019)

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