510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K191812Substantially Equivalent

ADI Cervical Interbody Fusion Device

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)

K191812 is the FDA 510(k) clearance record for ADI Cervical Interbody Fusion Device, a class II device, cleared for Additive Device, Inc. (Adi) D/B/A Restor3D on under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical). FDA's definition for product code ODP reads: "Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". 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 K191812.

Clearance record

Decision date
Received
(111 days to decision)
Product code
ODP Intervertebral Fusion Device With Bone Graft, Cervical
Regulation
21 CFR 888.3080
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 ODP

Trailing 12 months
24 clearances under product code ODP in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code ODP, trailing twelve months
MonthClearances
November 20253
December 20252
January 20265
February 20261
March 20262
April 20264
May 20262
June 20260
July 20263
August 20262
September 20260
October 20260