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510(k) Data Aggregation
K Number
K151540Device Name
MC BIO Supertack Tack 3mm, 4mm and 5mm
Manufacturer
Date Cleared
2016-05-26
(353 days)
Product Code
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
ELI-KA TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MC Bio Supertack tacks are used for the stabilization of absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area.
The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone.
General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.
The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio SUPERTACK system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone.
Gnereral patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.
Device Description
The MC Bio SUPERTACK System consists of 3mm, 4mm and 5mm bone tacks and associated instrumentation.
The tacks material consist of Titanium alloy, as specified in ASTM F136 STANDARD for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy, anodized blue color.
The devices are provided non-sterile.
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