FDA.reportPublic FDA data

Medicon Epiplating System

Primary DI
04046826319977
Brand
Medicon Epiplating System
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
68.80.49
Catalog number
68.80.49
Device description
healing cap for 68.80.68+69
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FZEProsthesis, Nose, Internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZEProsthesis, Nose, InternalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241253000Medicon Epiplating SystemCmf Medicon Surgical, Inc.2024-12-12FZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046826308605PrimaryGS10
04046826319977Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826308605040468263086054046826308605
04046826319977040468263199774046826319977

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbable, non-customizedA small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315492330
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046826002572Medicon03.05.1703.05.172026-04-30
04046826020507Medicon14.06.1214.06.122026-04-30
04046826023331Medicon15.70.1415.70.142026-04-30
04046826023362Medicon15.71.1415.71.142026-04-30
04046826050849Medicon47.30.1347.30.132026-04-30
04046826063764Medicon51.99.5051.99.502017-05-31
04046826032807Medicon24.26.1224.26.122026-04-13
04046826531508Medicon68.94.70A68.94.70A2026-04-02
04046826531522Medicon68.94.72A68.94.72A2026-04-02
04046826531539Medicon68.94.76A68.94.76A2026-04-02
04046826531515Medicon68.94.71A68.94.71A2026-04-01
04046826416942Medicon68.93.51A68.93.51A2026-03-25
04046826541385Medicon68.93.4268.93.422026-03-25
04046826495930Medicon Tray906.91.86906.91.862026-03-24
04046826495985Medicon Tray906.91.33906.91.332026-03-24
04046826447953Medicon Tray906.91.25906.91.252026-03-24
04046826495923Medicon Tray906.91.86906.91.862026-03-24
04046826495978Medicon Tray906.91.33906.91.332026-03-24
04046826445928Medicon Tray906.91.22906.91.222026-03-20
04046826445935Medicon Tray906.91.23906.91.232026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09321502015615BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502020732BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502021760BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502021777BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502034579BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040075BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040082BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040099BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
00841036204181HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-15
00841036203955HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203962HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203979HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203986HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203849HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-09
00841036203856HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-09
00841036203689HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203771HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203788HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203795HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203801HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203580HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203597HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203603HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203610HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203627HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203634HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203351HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203368HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203375HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203382HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04