Home / 510(k) Clearances / K102641

510(k) K102641

MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE by Neoortho Produtos Ortopedicos S/A — Product Code JEY

K102641 is an FDA 510(k) premarket notification submitted by Neoortho Produtos Ortopedicos S/A for the device "MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE". The FDA issued a decision of Substantially Equivalent on Dec 20, 2010. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Neoortho Produtos Ortopedicos S/A has 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 20, 2010
Date Received
Sep 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type
510(k)

Other clearances by Neoortho Produtos Ortopedicos S/A

  • K162874 — Cannulated Screws Neoortho (Jun 27, 2017)
  • K141103 — INTRAMEDULLARY NAIL AND SCREWS-NEONAIL (Sep 23, 2014)
  • K132852 — PEEK CAGE FOR THE VERTEBRAL SPINE (May 29, 2014)
  • K113733 — SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX (Mar 23, 2012)

Other clearances for product code JEY

  • K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions… (Aug 17, 2026)
  • K253206 — METICULY Patient-specific CMF solution (Jul 25, 2026)
  • K252246 — Leforte MMF System (Apr 2, 2026)
  • K253373 — Southern Craniomaxillofacial (CMF) System (Dec 19, 2025)
  • K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5… (Nov 7, 2025)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (Aug 16, 2024)
  • K240651 — MRI Universal (Jul 12, 2024)
  • K233874 — tmCMF Solution (Jul 11, 2024)
  • K232889 — METICULY Patient-specific titanium maxillofacial mesh implant (Apr 30, 2024)
  • K232350 — Stryker Facial iD System (Jan 13, 2024)

FDA data resources