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510(k) Data Aggregation
K Number
K113399Device Name
IFS SUBTALAR IMPLANT
Manufacturer
INTERNAL FIXATION SYSTEMS, INC.
Date Cleared
2011-12-20
(33 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
INTERNAL FIXATION SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Device Description
The IFS Subtalar Implant is a one-piece device made of Ti 6Al-4V ELI intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 diameter and length sizes (7mm through 12mm and 13mm through 18mm, respectively). The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.
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K Number
K110086Device Name
IFS PROFILE PLATES, SCREWS, AND WASHERS
Manufacturer
INTERNAL FIXATION SYSTEMS, INC.
Date Cleared
2011-09-09
(240 days)
Product Code
HRS, HWC, NDG
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
INTERNAL FIXATION SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula.
The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.
Device Description
IFS bone plates consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, and fibula. The washers are to function with screws to prevent the screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates, screws, and washers are a one-piece device made of Titanium 6Al-4V ELI or stainless steel.
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K Number
K071035Device Name
IFS BONE FIXATION DEVICES
Manufacturer
INTERNAL FIXATION SYSTEMS, INC.
Date Cleared
2007-08-13
(123 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
INTERNAL FIXATION SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IFS Bone Fixation Devices are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
***Warning: IFS Bone Fixation Devices are not indicated for spinal fixation.***
Device Description
The IFS Bone Fixation Devices consist of cancellous, malleolar, or cortical screws ranging from 6 to 160mm in length and 1.5mm to 7.3mm in diameter. Threaded, spaded or blunt guide wires range from 0.028 to 0.188 of an inch in diameter and 4 to 12 inches in length. All IFS Bone Fixation Devices are manufactured using 316L stainless steel.
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K Number
K061620Device Name
IFS CANNULATED BONE SCREW
Manufacturer
INTERNAL FIXATION SYSTEMS, INC.
Date Cleared
2006-07-26
(47 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
INTERNAL FIXATION SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intended Use of the IFS Cannulated Bone Screw is for the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.
Device Description
The IFS Cannulated Screw is a self-tapping, self-drilling screw with a cancellous thread that can be guided into position by guidewire placement. Partial or fully threaded screws are available in 3.0mm, 3.5mm, and 4.0mm thread diameters and 10mm to 75mm in length.
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