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510(k) Data Aggregation
K Number
K212391Device Name
MCI-Neuro Fixation System
Manufacturer
MCI Medical Concept Innovation Inc.
Date Cleared
2022-10-21
(445 days)
Product Code
GWO, GXR, HBW
Regulation Number
882.5320Why did this record match?
Applicant Name (Manufacturer) :
MCI Medical Concept Innovation Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
Device Description
The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized.
MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.
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K Number
K182758Device Name
MCI - CMF System
Manufacturer
MCI Medical Concept Innovation Inc.
Date Cleared
2019-12-05
(433 days)
Product Code
JEY, DZL
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
MCI Medical Concept Innovation Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MCI - CMF System is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.
Device Description
The bone plates are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6AI-4V (ASTM F136) and are available in different sizes and shapes, according the site of the implantation and the extension of the fracture. The surface of plates and screws are colored-anodized. MCI - CMF System implant devices are for single use. The devices are provided non-sterile and must be properly cleaned, disinfected and sterilized before use, according the recommendations provided in the Instructions for Use.
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