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Found 7 results
510(k) Data Aggregation
K Number
K061748Device Name
FRAGMENT PLATE SYSTEM
Manufacturer
HAND INNOVATIONS, LLC.
Date Cleared
2006-07-17
(26 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
HAND INNOVATIONS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proposed Mini Fragment Plates are intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomax, illofacial skeleton.
Device Description
The proposed Mini Fragment Plates are a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Fragment Plates that are provided in the following design configurations: Straight, Y, Right Hockey Stick, and Left Hockey Stick. Pegs; Screws; and K-Wires. Included in the sterilization tray are the following re-useable instruments: Peg drivers, Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: F.A.S.T. Guide Technology™ Drill Guide, Drill bits.
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K Number
K060864Device Name
MULTIDIRECTIONAL THREADED PEG
Manufacturer
HAND INNOVATIONS, LLC.
Date Cleared
2006-04-28
(29 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
HAND INNOVATIONS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.
Device Description
The proposed Multidirectional Threaded Peg is manufactured from Cobalt Chromium (CoCr) and is available in 2.5 mm diameter and in a variety of lengths, ranging from 10 – 30 mm in 2 mm increments to accommodate varying patient anatomies and fracture morphologies.
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K Number
K060294Device Name
DIAPHYSEAL PLATE
Manufacturer
HAND INNOVATIONS, LLC.
Date Cleared
2006-03-22
(44 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
HAND INNOVATIONS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proposed Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone.
Device Description
The proposed Diaphyseal Plate is fabricated from 316L Stainless Steel and is available in five configurations - 6, 8, 10, 12, and 14 hole plate configuration. The proposed Diaphyseal Plate has both slotted holes, for accommodating the Multi-Directional Screws, and round holes for accommodating either Multi-Directional or 90° Lock Screws. 90° Set Screws are used to secure the 90° Lock Screws within the plate to prevent backout.
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K Number
K060290Device Name
SHOULDER FIXATION SYSTEM
Manufacturer
HAND INNOVATIONS, LLC.
Date Cleared
2006-02-27
(21 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
HAND INNOVATIONS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
Device Description
The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Shoulder Plates Shoulder Nail Plates Multidirectional and 90° Lock Screws 90° Set Screws Pegs Included in the sterilization tray are the following re-useable instruments: Peg drivers Other standard surgical tools.
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K Number
K052294Device Name
SHOULDER NAIL PLATE
Manufacturer
HAND INNOVATIONS, LLC.
Date Cleared
2005-10-21
(59 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
HAND INNOVATIONS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
Device Description
The bilaterally symmetric Shoulder Nail Plate is intended to treat fractures in both left and right Humerus. The plate segment of the Shoulder Nail Plate is intended to be attached to the metaphysis of the humerus. The nail segment of the Shoulder Nail Plate is intended to be inserted into the humeral diaphysis for optimal stabilization of the fracture.
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K Number
K052248Device Name
DORSAL NAIL PLATE, ANATOMICAL
Manufacturer
HAND INNOVATIONS, LLC.
Date Cleared
2005-09-14
(27 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
HAND INNOVATIONS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dorsal Nail Plate™, Anatomical is intended for the fixation of fractures and osteotomies involving the distal Radius.
Device Description
The Dorsal Nail Plate™, Anatomical is intended to treat fractures in both left and right Radius. The distal segment of the nail plate is intended to be attached to the dorsal surface of the distal Radius. The proximal segment of the nail plate is intended to be inserted into the Radial shaft.
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K Number
K051728Device Name
MODIFICATION TO SHOULDER FIXATION SYSTEM
Manufacturer
HAND INNOVATIONS, LLC.
Date Cleared
2005-07-20
(23 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
HAND INNOVATIONS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
Device Description
The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: • Shoulder Plates • Multidirectional and 90° Lock Screws • 90° Set Screws • Pegs Also, provided in the sterilization tray are the re-useable instruments
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