Home / 510(k) Clearances / K241253

510(k) K241253

Medicon Epiplating System by Cmf Medicon Surgical, Inc. — Product Code FZE

K241253 is an FDA 510(k) premarket notification submitted by Cmf Medicon Surgical, Inc. for the device "Medicon Epiplating System". The FDA issued a decision of Substantially Equivalent on December 12, 2024. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. Cmf Medicon Surgical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2024
Date Received
May 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Nose, Internal
Device Class
Class II
Regulation Number
878.3680
Review Panel
SU
Submission Type

Other clearances by Cmf Medicon Surgical, Inc.

  • K242764 — MediRod Pedicle Screw System (November 13, 2024)
  • K212126 — MediExpand Cervical Expandable VBR System (April 4, 2022)
  • K190349 — MediExpand TL Expandable VBR System (October 24, 2019)

Other clearances for product code FZE

  • K161548 — Osseointegrated Fixtures (December 1, 2016)
  • K090803 — HANSON MEDICAL FACIAL IMPLANTS (June 30, 2010)
  • K090630 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) (June 2, 2009)
  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)
  • K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (November 22, 1999)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)
  • K981833 — SILIMED NASAL L SHAPED IMPLANT (June 26, 1998)

FDA data resources