510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191047Substantially Equivalent

ADI TiDAL Osteotomy Wedge

Additive Device, Inc. (Adi) D/B/A Restor3D, Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191047 is the FDA 510(k) clearance record for ADI TiDAL Osteotomy Wedge, a class II device, cleared for Additive Device, Inc. (Adi) D/B/A Restor3D on under FDA product code PLF (Bone Wedge). FDA's definition for product code PLF reads: "Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia". FDA records list 2 510(k) clearances for Additive Device, Inc. (Adi) D/B/A Restor3D, from to . As of , FDA records show no recalls naming K191047.

Clearance record

Decision date
Received
(200 days to decision)
Product code
PLF Bone Wedge
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Additive Device, Inc. (Adi) D/B/A Restor3D 311 W. Corporation St., Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLF

Trailing 12 months
1 clearance under product code PLF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PLF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260