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510(k) Data Aggregation
K Number
K182991Device Name
EPIC Extremity Fusion Plate System
Manufacturer
EPIC Extremity, LLC
Date Cleared
2019-02-13
(107 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
EPIC Extremity, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EPIC Extremity Fusion Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet and ankles, including distal tibia. The plates/screws are intended for single use only.
Device Description
The EPIC Extremity Fusion Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.5mm/5.5mm locking and non-locking screws that mate into the plates, 5.5mm fully and partial threaded cancellous, 5.5mm cannulated partial threaded cancellous bone screws as well as various instruments to assist in implanting the system.
The EPIC Extremity Fusion Plate System is also designed to be used with various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).
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K Number
K172441Device Name
EPIC Extremity Fracture Plate System
Manufacturer
EPIC Extremity, LLC
Date Cleared
2017-11-06
(87 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
EPIC Extremity, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EPIC Extremity Fracture Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. The plates/screws are intended for single use only.
Device Description
The EPIC Extremity Fracture Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.0mm locking and non-locking screws that mate into the plates, 4.0mm fully and partial threaded cancellous bone screws as well as various instruments to assist in implanting the system.
The EPIC Extremity Fracture Plate System is also designed to accept the 2.7mm/3.5mm locking/non-locking screws and various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).
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K Number
K163038Device Name
EPIC Extremity Snap-Off Screw
Manufacturer
EPIC EXTREMITY, LLC
Date Cleared
2017-02-28
(120 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
EPIC EXTREMITY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EPIC Extremity Snap-Off Screw is indicated for use in fixation of bone fractures or bone reconstruction.
Examples include:
*Fixation of small bone fragments
* Weil osteotomy
*Mono-cortical fixation
*Osteotomies and fracture fixation in the foot and hand
The Snap-Off Screw is intended for single use only.
Device Description
The EPIC Extremity Snap-Off Screw will consist of headed snap off screws of various lengths and instruments to assist in implanting the devices.
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K Number
K153340Device Name
Epic Extremity Plate System
Manufacturer
Epic Extremity, LLC
Date Cleared
2016-02-09
(82 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Epic Extremity, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Epic Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone of the hand, fingers and toes. The system may be used in both adult and pediatric patients. The plates/screws are intended for single use only.
Device Description
The Epic Extremity Plate System consists of multiple plate families of various anatomical sizes and shapes, 2.7mm and 3.5mm locking and nonlocking screws which mate into the plates, as well as various instruments to assist in implanting the system.
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K Number
K153333Device Name
Epic Extremity Cannulated Screw System
Manufacturer
Epic Extremity, LLC
Date Cleared
2016-01-19
(61 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Epic Extremity, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device.
Screws are intended for single use only.
Device Description
The Epic Extremity Cannulated Screw System will consist of multiple diameter headed and headless cannulated screws of various lengths and instruments to assist in implanting the system.
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