FDA.reportPublic FDA data

MCI - Medical Concept Innovation, Inc.

Primary DI
00811687030972
Brand
MCI - Medical Concept Innovation, Inc.
Company
MCI-MEDICAL CONCEPT INNOVATION INC
Model
A01.01.0218
Catalog number
A01.01.0218
Device description
CORTICAL SCREW AP 2.0 X 6MM-TI-CROSS-DRIVE
Published
2022-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZLScrew, Fixation, Intraosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182758000MCI - CMF SystemMci Medical Concept Innovation, Inc.2019-12-05JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811687030972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811687030972008116870309728116870309720811687030972

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
954-306-2521customer.service@mci-medical.com

Regulatory Flags#

DUNS number
080815653
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811687032877MCI - Medical Concept Innovation, Inc.A01.01.1137A01.01.11372024-08-27
00811687032884MCI - Medical Concept Innovation, Inc.A01.01.1138A01.01.11382024-08-27
00811687031986MCI - Medical Concept Innovation, Inc.A01.02.1123A01.02.11232024-08-07
00811687031993MCI - Medical Concept Innovation, Inc.A01.02.1011A01.02.10112024-08-07
00811687032006MCI - Medical Concept Innovation, Inc.A01.02.1013A01.02.10132024-08-07
00811687032013MCI - Medical Concept Innovation, Inc.A01.02.1012A01.02.10122024-08-07
00811687032549MCI - Medical Concept Innovation, Inc.A01.01.2310A01.01.23102024-08-07
00811687032556MCI - Medical Concept Innovation, Inc.A01.01.1004A01.01.10042024-08-07
00811687032563MCI - Medical Concept Innovation, Inc.A01.01.3010A01.01.30102024-08-07
00811687032587MCI - Medical Concept Innovation, Inc.A01.02.1101A01.02.11012024-08-07
00811687032594MCI - Medical Concept Innovation, Inc.A01.02.1125A01.02.11252024-08-07
00811687032600MCI - Medical Concept Innovation, Inc.A01.02.1107A01.02.11072024-08-07
00811687032617MCI - Medical Concept Innovation, Inc.A01.02.1110A01.02.11102024-08-07
00811687032624MCI - Medical Concept Innovation, Inc.A01.02.1127A01.02.11272024-08-07
00811687032631MCI - Medical Concept Innovation, Inc.A01.02.1109A01.02.11092024-08-07
00811687032648MCI - Medical Concept Innovation, Inc.A01.02.1103A01.02.11032024-08-07
00811687032655MCI - Medical Concept Innovation, Inc.A01.02.1106A01.02.11062024-08-07
00811687032679MCI - Medical Concept Innovation, Inc.A01.01.4022A01.01.40222024-08-07
00811687032709MCI - Medical Concept Innovation, Inc.A01.01.1153A01.01.11532024-08-07
00811687032747MCI - Medical Concept Innovation, Inc.A01.01.1145A01.01.11452024-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800089458967Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458974Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458981Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458998Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089459001Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
ESAM23053121STOMA®Storz am Mark GmbHDZL2025-04-30
ESAM23060091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23060111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23060131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM21221001STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23053141STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23048001STOMA®Storz am Mark GmbHDZL2020-11-09
ESAM23049001STOMA®Storz am Mark GmbHDZL2020-08-27
08806390878029Jeil Bone Fixation SystemJeil Medical CorporationDZL2019-06-18
10810004515700CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515748CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515755CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515762CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515779CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515786CMF VISIONAREVISIONARE, LLCDZL2019-02-21