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510(k) Data Aggregation
K Number
K102387Device Name
MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES
Manufacturer
MEDISCOPE MANUFACTURING, INC.
Date Cleared
2011-10-24
(427 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MEDISCOPE MANUFACTURING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mediscope Asymmetrical Compression Staple is intended to be used for fixation such as: mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Device Description
The Mediscope Compression Staple is a single patient use device made of surgical grade The Medisope Oompression Stapie is cross the fusion site of two bones from the adiacent position. The design features of the Mediscope Compression Staple are summarized below: - Manufactured from nickel-free stainless steel . - 5 sizes . - Barbs to prevent back out .
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