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Found 5 results
510(k) Data Aggregation
K Number
K111908Device Name
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
Manufacturer
BIOMET MICROFIXATION, INC.
Date Cleared
2011-11-29
(147 days)
Product Code
HWC, 87H, HRS
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIOMET MICROFIXATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.
Device Description
Biomet Microfixation Sternal Closure System contains a variety of plates and 2.4mm and 2.7mm diameter self-drilling screws with maximum length of 20mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used. Material: Titanium. Sterility Information: The Biomet Microfixation Sternal Closure System will be marketed as non-sterile, single use devices. Validated steam sterilization recommendations are included in the package insert.
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K Number
K110574Device Name
BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
Manufacturer
BIOMET MICROFIXATION, INC.
Date Cleared
2011-05-18
(78 days)
Product Code
HRS, 87H
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
BIOMET MICROFIXATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biomet Microfixation SternaLock Blu Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures
Device Description
Biomet Microfixation Sternal Closure System contains plates and 2.4mm and 2.7mm diameter self-drilling screw with maximum length of 20mm. The screw is designed so that a predrilled hole is not required, but may be used.
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K Number
K091058Device Name
ADKINS STRUT
Manufacturer
BIOMET MICROFIXATION, INC.
Date Cleared
2009-07-22
(100 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
BIOMET MICROFIXATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.
Device Description
The Biomet Microfixation Adkins Strut is a surgical implant intended to aid treatment of Pectus Excavatum and other sternal deformities. The strut provides the surgeon with a means to reposition bony structures (sternum, breastbone) by providing internal stabilization and fixation of the chest wall following surgical procedures such as the Ravitch procedure. The struts are available in various lengths with two holes on each end for sutures to secure the bar to the lateral chest wall. The titanium struts are used when the patient has a nickel allergy.
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K Number
K081067Device Name
FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
Manufacturer
BIOMET MICROFIXATION, INC.
Date Cleared
2008-05-09
(24 days)
Product Code
JEY
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
BIOMET MICROFIXATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
Device Description
The Mandibular Fracture / Reconstructive Devices (TraumaOne) are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for internal fixation of mandibular fractures and reconstruction procedures. The screws have locking head features. The plates have threaded through holes (which allows them to work with either the locking screws) and will include straight, angle, double angle, and crescent options with various lengths and thickness.
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K Number
K071577Device Name
BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
Manufacturer
BIOMET MICROFIXATION, INC.
Date Cleared
2007-09-06
(90 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
BIOMET MICROFIXATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K061384 for repairing Pectus Excavatum and other sternal deformities when additional stabilization is necessary.
Device Description
The LactoSorb® Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Biomet Microfixation Pectus Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity. The LactoSorb® Pectus Stabilizer is a resorbable implant and does not require removal.
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