ADI TiDAL Osteotomy Wedge
K-Number: K191047 · 2019-11-05
Decision Date2019-11-05
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ADI TiDAL Osteotomy Wedge is a medical device manufactured by Additive Device, Inc. (Adi) D/B/A Restor3D. It received FDA 510(k) clearance on 2019-11-05 under approval number K191047. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ADI TiDAL Osteotomy Wedge?
ADI TiDAL Osteotomy Wedge is a medical device that received FDA 510(k) clearance on 2019-11-05. It is manufactured by Additive Device, Inc. (Adi) D/B/A Restor3D. The 510(k) number is K191047.
When was ADI TiDAL Osteotomy Wedge approved by the FDA?
ADI TiDAL Osteotomy Wedge received FDA 510(k) clearance on 2019-11-05, under approval number K191047.
What company makes ADI TiDAL Osteotomy Wedge?
ADI TiDAL Osteotomy Wedge is manufactured by Additive Device, Inc. (Adi) D/B/A Restor3D.
What is the FDA product code for ADI TiDAL Osteotomy Wedge?
The FDA product code for ADI TiDAL Osteotomy Wedge is PLF.
Other Devices by Additive Device, Inc. (Adi) D/B/A Restor3D
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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.