510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102641Substantially Equivalent

Mini and Micro Fragments Reconstruction System-Neoface

Neoortho Produtos Ortopedicos S/a, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102641 is the FDA 510(k) clearance record for MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE, a class II device, cleared for Neoortho Produtos Ortopedicos S/A on under FDA product code JEY (Plate, Bone). FDA records list 6 510(k) clearances for Neoortho Produtos Ortopedicos S/A, from to . As of , FDA records show no recalls naming K102641.

Clearance record

Decision date
Received
(98 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Neoortho Produtos Ortopedicos S/A 11234 El Camino Real, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JEY

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