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510(k) Data Aggregation
K Number
K161303Device Name
dynaMX Compression Plate
Manufacturer
MX ORTHOPEDICS, CORP.
Date Cleared
2017-01-26
(261 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MX ORTHOPEDICS, CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The dynaMXTM Compression Plate is indicated for fixation of small fragments, osteolomics, atthrodeses, replantations, and reconstructions of small bones and small fragments.
Device Description
The dynaMX™ Compression Plate provides a means of fixation for small bones and small fragments. The dynaMÄ™ Compression Plate is made of biocompatible Nitinol. The bridge of the implant is designed to exhibit superelastic properties at room temperature.
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K Number
K153129Device Name
dynaMX Tabbed Staple
Manufacturer
MX Orthopedics, Corp.
Date Cleared
2016-01-28
(90 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MX Orthopedics, Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The dynaMXTM Tabbed Staple is indicated for:
· Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,
· Fixation of proximal tibial metaphysis osteotomy.
Device Description
The dynaMX™ Tabbed Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.
- The dynaMÄ™ Tabbed Staples are made of biocompatible Nitinol. The legs of the . staple are designed to exhibit superelastic properties at room temperature.
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K Number
K143622Device Name
dynaMX Compression Staple
Manufacturer
MX Orthopedics, Corp.
Date Cleared
2015-06-17
(177 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MX Orthopedics, Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The dynaMX™ Compression Staple is indicated for:
Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,
Fixation of proximal tibial metaphysis osteotomy
Device Description
The dynaMX Compression Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.
The dynaMX Compression Staples are made of biocompatible Nitinol. The legs of the staple are designed to exhibit superelastic properties at room temperature.
Staples with a bridge length of 11mm and longer are designed with a bridge that can be bent to contour to the bone surface.
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