510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K952812Substantially Equivalent

3I Oral/maxillofacial Bone Fixation System: Cocrmo Alloy (Vitalium) Bone-Mesh/plate & Screws

ZimVie US Corp LLC, West Palm Baeach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952812 is the FDA 510(k) clearance record for 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS, a class II device, cleared for Implant Innovations, Inc. on under FDA product code JEY (Plate, Bone). FDA records list 123 510(k) clearances for ZimVie US Corp LLC, from to . As of , FDA records show no recalls naming K952812.

Clearance record

Decision date
Received
(72 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Implant Innovations, Inc. 3071 Continental Dr., West Palm Baeach FL
510(k) summary
Statement
Third party review
No

Clearances, product code JEY

Trailing 12 months
4 clearances under product code JEY in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260
November 20260