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Found 4 results
510(k) Data Aggregation
K Number
K250141Device Name
Synthecure Synthetic Calcium Sulfate
Manufacturer
Austin Medical Ventures, Inc.
Date Cleared
2025-05-16
(119 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
**Austin **Medical Ventures, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthecure Synthetic Calcium Sulfate is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Synthecure Synthetic Calcium Sulfate resorbs and is replaced with bone during the healing process.
Synthecure is provided sterile for single use only. Synthecure is biodegradable and biocompatible and may be used at an infected site.
Device Description
Synthecure Synthetic Calcium Sulfate is indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Synthecure is biocompatible and may be implanted at an infected site. Synthecure Synthetic Calcium Sulfate is presented as a powder and mixing solution which when mixed together forms a paste which may be injected, digitally implanted or applied to a mold provided to produce pellets.
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K Number
K181528Device Name
Austin Miller Large External Fixation System
Manufacturer
Austin Miller Trauma LLC
Date Cleared
2019-02-28
(262 days)
Product Code
KTT, JDW
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
**Austin **Miller Trauma LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Austin Miller External Fixation System is intended to be used on adult or pediatic patients for stabilization of the long bones, feet, and pelvis. The most common indication of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures, infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.
Device Description
The Austin Miller External Fixation System is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided non-sterile.
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K Number
K161587Device Name
Memodyn Staple
Manufacturer
AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT
Date Cleared
2017-02-01
(238 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
**AUSTIN **& ASSOCIATES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the foot, ankle and hand.
Device Description
Memodyn Staple is a nitinol alloy ASTM F2063-12 memory staple that comes in sizes ranging from 8mm to 20mm, and is used for bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.
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K Number
K061422Device Name
SURGICAL DRAPES
Manufacturer
AUSTIN MEDICAL, INC.
Date Cleared
2006-09-25
(125 days)
Product Code
KKX, KKK
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
**AUSTIN **MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical drapes made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.
Device Description
Various types of surgical drapes
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