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Found 52 results
510(k) Data Aggregation
K Number
K230067Device Name
Para-Fix External Fixation System
Manufacturer
New Paradigm Biomedical
Date Cleared
2023-09-22
(256 days)
Product Code
LXT, KTT
Regulation Number
888.3030Why did this record match?
Product Code :
LXT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Para-Fix External Fixation System is intended to provide stabilization of open and/or unstable fractures and where tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
The specific indications for the Para-Fix External Fixation System include:
· Bone fracture fixation
· Osteotomy
· Arthrodesis
· Correction of deformity
· Revision procedure where other treatments or devices have been unsuccessful
· Bone reconstruction procedures
Device Description
The New Paradigm Biomedical (NPB) Para-Fix External Fixation System is intended for use in external fixation of various long bone fractures, including tibial, femoral, pelvic, and humeral fractures in adults. The Para-Fix system consists of implants, & instrumentation for external fixation. The system features implants (Schanz Screws) in various diameters (05 – 6mm) and lengths (120 – 300mm) to accommodate different anatomic sizes of patients. Schanz Screws are manufactured from medical grade stainless steel per ASTM F138. Para-Fix frame components include Clamps are available in Combination (pin to rod, rod to rod) or Multi-Pin clamps are manufactured from stainless steel. Ø11mm rods are available in lengths ranging from 65 – 500mm and are manufactured from carbon fiber. The Para-Fix system is provided non-sterile.
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K Number
K131636Device Name
POLARUS CONNECT
Manufacturer
ACUMED LLC
Date Cleared
2013-10-10
(128 days)
Product Code
LXT, HRS, HSB
Regulation Number
888.3030Why did this record match?
Product Code :
LXT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus.
Device Description
The Acumed Polarus® Connect System of bone plates, intramedullary nails, screws and accessories are designed to provide fixation for fractures of the humerus while they heal. The Polarus® Connect System also includes instruments to facilitate placement of implants.
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K Number
K132704Device Name
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
Manufacturer
BIOMET
Date Cleared
2013-10-09
(41 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Product Code :
LXT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.
Device Description
The Distal Radius Volar Rim Plating System consists of a series of plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr used in bone fixation and the management of fractures and reconstructive surgeries in narrow to standard head widths.
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K Number
K112345Device Name
DISTAL VOLAR RADIUS PLATING SYSTEMS
Manufacturer
MEDOS INTERNATIONAL SARL
Date Cleared
2011-10-31
(77 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Product Code :
LXT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K090374Device Name
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
Manufacturer
DEPUY ORTHOPAEDICS, INC.
Date Cleared
2009-03-11
(22 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Product Code :
LXT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile DVR Anatomic Plating System is intended for fixation of fractures and osteotomies of the distal radius.
Device Description
The Sterile DVR Anatomic Plating System offers the DVR plating system of plates and screws in a sterile configuration.
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K Number
K073135Device Name
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
Manufacturer
SYNTHES (USA)
Date Cleared
2008-01-29
(83 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Product Code :
LXT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fixation of proximal and/or distal tibial fractures, with or without extension into the tibial shaft.
Device Description
Synthes Hybrid External Fixator Modifications are components of the Synthes Hybrid External Fixator, a ring and wire based external fixator that forms a construct intended for the stabilization of complex proximal and/or distal tibial fractures. It is designed for use with the Synthes Large Exernal Fixator and may be used in conjunction with other fixation methods. The proposed components consist of an Adjustable Wire/Pin Clamp, a Low-Profile Adjustable Wire/Pin Clamp and Ring-To-Rod Clamp.
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K Number
K063832Device Name
SYNTHES (USA) ELBOW HINGE FIXATOR
Manufacturer
SYNTHES (USA)
Date Cleared
2007-03-07
(71 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Product Code :
LXT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability.
The indications for guided joint bridging with external fixators are:
-Delayed treatment of dislocated and stiff elbows
-Chronic, persistent joint instability
-Acute joint instability after complex ligament injuries
-Unstable elbow fractures
-Additional stabilization of post-operative unstable internal fixation
The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator for adults, and with the components of the Synthes Medium External Fixator for children and small stature adults.
Device Description
The Synthes Elbow Hinge Fixator consists of two rods, which are interconnected through a riveted joint, allowing a hinge-like movement. The rods are made of carbon fiber reinforced PEEK, and the joint is made of stainless steel. The overall length of the device is 180mm and the achievable range of motion averages 270 degrees.
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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?
Product Code :
LXT
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
K060403Device Name
PTA (PROGRESSIVE TIBIAL ALIGNMENT)
Manufacturer
MERIDIAN MEDICAL
Date Cleared
2006-03-28
(41 days)
Product Code
LXT, HWC
Regulation Number
888.3030Why did this record match?
Product Code :
LXT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PTA (Progressive Tibial Alignment) external fixation system is a modular system with the components of: joints, bars, clamps or screws. Such components form a device indicated for reconstruction and corrections of bone segments of the human body.
The PTA is for progressive realignment of the knee.
Device Description
The PTA has multiple components of metallic bone fixation appliances and accessories. It is designed for a progressive correction of the lower limb using tibial osteotomy. This device is composed of a main section of a bar and proximal distraction unit upon which are connected the clamps and grasping components. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316 LVM, ISO 5832-1.
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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?
Product Code :
LXT
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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