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FDA 510(k)

ADI TiDAL Osteotomy Wedge

K-Number: K191047 · 2019-11-05

ApplicantAdditive Device, Inc. (Adi) D/B/A Restor3D
Decision Date2019-11-05
Product CodePLF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADI TiDAL Osteotomy Wedge is the device name listed in this FDA 510(k) record. The listed applicant is Additive Device, Inc. (Adi) D/B/A Restor3D. It received FDA 510(k) clearance on 2019-11-05 under 510(k) 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. The listed applicant is Additive Device, Inc. (Adi) D/B/A Restor3D. The 510(k) number is K191047.

When did ADI TiDAL Osteotomy Wedge receive FDA 510(k) clearance?

ADI TiDAL Osteotomy Wedge received FDA 510(k) clearance on 2019-11-05, under 510(k) number K191047.

Who is the listed applicant for ADI TiDAL Osteotomy Wedge?

The FDA 510(k) record lists Additive Device, Inc. (Adi) D/B/A Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADI TiDAL Osteotomy Wedge?

The FDA product code for ADI TiDAL Osteotomy Wedge is PLF.

Other records listing Additive Device, Inc. (Adi) D/B/A Restor3D as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191812ADI Cervical Interbody Fusion Device

Related Devices (Code: PLF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLCK252254Osteotomy Wedge SystemSinaptic SurgicalK251791Auxano® Wedge Fixation SystemAuxano Medical, LLCK240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.K243231Trigon PEEK HA WedgesNvision Biomedical TechnologiesK234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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