Search Results
Found 1 results
510(k) Data Aggregation
K Number
K220892Device Name
ExsoMed INnate NanoTM Lag Screw System
Manufacturer
Date Cleared
2022-04-27
(30 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ExsoMed Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ExsoMed INnate Nano™ Lag Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Device Description
The purpose of this Special 510(k) is to add additional sizes and geometry to InFrame™ Cannulated Fixation System. The ExsoMed INnate Nano Lag Screw System includes cannulated stainless screws with a diameter of 1.5mm and lengths ranging from 6 mm to 26 mm.
Ask a Question
Ask a specific question about this device
Page 1 of 1