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510(k) Data Aggregation
K Number
K223847Device Name
CREED Cannulated Screws
Manufacturer
GLW, Inc.
Date Cleared
2023-01-25
(34 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
GLW, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, nonunions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.
Device Description
CREED™ Cannulated Screws Subject device consists of components that will be available in Ø2.5mm thread diameter and lengths ranging from 20-44 mm. They areheadless compression screws. All screws are self-drilling and self-tapping. The screws are Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws. A variety of instrumentation is offered as part of the kit to facilitate delivery of the screws. The screws are provided sterile via Gamma irradiation.
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K Number
K221489Device Name
Artemis Proximal Femoral Nail System
Manufacturer
GLW, Inc.
Date Cleared
2022-10-27
(157 days)
Product Code
HSB, HWC
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
GLW, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Artemis Proximal Femoral Nail System is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.
Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch.
Device Description
The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Proximal Femoral Nail Kit Long, Locking Screw, Lag Screw, and optional anti-rotational locking pins) as well as non-sterile, reusable, Class I and II surgical instruments.
The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).
The Artemis Nails are available in short or long lengths from 180mm to 440mm and are cylindrical rods with preassembled Set Screws. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm. Optional Anti-rotational Locking Pins are also available to aid in rotational stability.
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K Number
K201379Device Name
Artemis Proximal Femoral Nail System
Manufacturer
GLW, Inc.
Date Cleared
2021-02-19
(269 days)
Product Code
HSB, HWC
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
GLW, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Artemis Proximal Femoral Nail System is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.
Device Description
The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Locking Screw, and Lag Screw) as well as non-sterile, reusable, Class I and II surgical instruments. The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).
The Artemis Nail is a cylindrical rod with a preassembled 4mm Set Screw, available in one size with a distal diameter of 11mm, a proximal diameter of 16.4mm, and a length of 180mm. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm.
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