卡丁健康 骨科解决方案产品介绍说明书

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Cardinal Health™
Orthopedic Solutions
• Mini Fragment (Locking and Non-Locking)
• Extremities (Hand and Foot)
• Small Fragment (Locking and Non-Locking)
• Cannulated Screws
1Humerus • 3.5mm Locking Proximal Humerus Plate • 4.5mm Narrow and Broad Locking Plates Radius
• 2.4mm Locking Distal Radius Plate
• 3.5mm Locking Plate Fibula • 3.5mm Locking One-Third Tubular Plate Ulna
• 3.5mm Locking Plate
Femur
• 6.5 and 7.3mm Cannulated Screws
• 4.5mm Narrow and Broad
Locking Plates • 4.5mm Locking Condylar Plate Lower extremity/foot and ankle
• 2.4, 3.0, 3.5, 4.0, 4.5, 6.5 and 7.3mm
Cannulated Screws
• 2.0, 2.4, 2.7 and 3.5mm Foot Specific Plates
• Calcaneal Plate
• Locking T, Y, Adaption and Straight Plates Pelvis
• 6.5 and 7.3mm
Cannulated Screws
• 3.5mm Locking
Reconstruction Plate Tibia
• 4.0 and 4.5mm Cannulated Screws
• 3.5mm Locking Proximal Tibia Plate (Standard and Low Bend)
• 4.5mm Locking Proximal Tibia Plate
• 3.5mm Locking Medial Distal Tibia Plate (Low Bend)
• Large External Fixator
Clavicle
• 3.5mm Locking Reconstruction Plate
Hip
• 6.5 and 7.3mm Cannulated Screws
• Trochanteric Nail (Short and Long) with 11.0mm Lag Screw*
Upper extremity/hand • 2.4 and 3.0mm Cannulated Screws
• 1.0, 1.3, 1.5, 2.0 and 2.4mm Hand Specific Plates
*Pending 510(k) submission.
2
Cardinal Health™ Plates
Our plates come in two material options and meet the required industry standards to help ensure quality and consistency.
• FDA premarket notification clearances: K133536, K133541, K122489, K131480
and K133452
Locking One-Third Tubular Plate
EM: 241.351.EM | CH: P2AL435-05
3.5mm Locking Reconstruction Plate
EM: 245.051.EM | CH: P2B535-084
3.5mm Locking Proximal Humerus Plate
EM: 241.901.EM | CH: P2H235-01
3.5mm Locking T-Plate
EM: 241.152.EM | CH: P2B635-14
1.3mm Straight Plate
EM: 221.306.EM | CH: P213-01
EM = Emerge Medical Catalog Number
CH = Cardinal Health Catalog Number 316L Stainless Steel
Low carbon, high strength medical implant-grade
stainless steel
• Meets ASTM F1381 and F1392
Ti-6Al-4V ELI Titanium Alloy
High strength, medical implant-grade
titanium alloy
• Meets ASTM F1363
1.3mm Ti Straight Plate
EM: 421.306.EM | CH: P413-01
2
3
1.0mm
üü
1.3mm ü
ü
1.5mm üü
2.0mm Locking ü2.0mm Non-Locking ü
ü
2.4mm Locking ü2.4mm Non-Locking üü
Mini Fragment / Extremities: Foot 2.0mm Locking
ü
2.0mm Non-Locking ü
ü
2.4mm Locking ü2.4mm Non-Locking ü
ü
2.7mm Locking ü2.7mm Non-Locking ü
Small Fragment 3.5mm Straight Plate (Locking and Non-Locking)ü
3.5mm Reconstruction Plate (Locking and Non-Locking)
ü3.5mm T-Plate (Oblique and Right Angle) (Locking and Non-Locking)ü 3.5mm One-Third Tubular Plate (Locking and Non-Locking)ü
3.5mm Locking Proximal Humerus Plate ü
3.5 Locking Proximal Humerus Plate (EM: 241.901.EM | CH: P2H235-01) with 3.5mm Locking and 3.5mm Cortex Screws
4Cardinal Health ™ Screws
Cardinal Health offers five different types of screws — cannulated, shaft, cortex, cancellous and locking screws.
Designed for use with instruments commonly available to Orthopedic Surgeons Self-drilling and self-tapping Choice of multiple thread lengths and diameters Reverse cutting flutes to assist in removal Available in medical implant-grade stainless steel and titanium Cannulated screws are made in the USA Compliant with industry standards and requirements — FDA premarket notification clearances: K102343, K122489, K131480 and K133536All corresponding washers, guide wires, cannulated drill bits and instrumentation are available üüüüüü
üü
5
1.0mm Cortex Screw üüüüüCruciate
1.3mm Cortex Screw üüüüüCruciate
1.5mm Cortex Screw üüüüüCruciate
2.0mm Locking Screw üüüüT6
2.0mm Cortex Screw üüüüüüT6 and Cruciate
2.4mm Locking Screw üüüüüüT6
2.4mm Cortex Screw üüüüüüT6 and Cruciate Mini Fragment / Extremities: Foot
2.0mm Locking Screw üüüüT6
2.0mm Cortex Screw üüüüüüT6 and Cruciate
2.4mm Locking Screw üüüüT6
2.4mm Cortex Screw üüüüüüT6 and Cruciate
2.7mm Locking Screw üüüüT8
2.7mm Cortex Screw üüüüüüT8 and Hex (2.5mm)Small Fragment
2.7mm Cortex Screw üüüüüüT8 and Hex (2.5mm)
3.5mm Cortex Screw üüüüüT15 and Hex (2.5mm)
3.5mm Shaft Screw üüüüüHex (2.5mm)
3.5mm Locking Screw üüüüT15
4.0mm Cancellous Screw üüFull thread Partial thread üüHex (2.5mm)Cannulated Screws
2.4mm Cannulated Screw üüShort (1/4 thread) Long (1/2 thread)üüüüüT8
3mm Cannulated Screw üüShort (1/3 thread) Long (1/2 thread)üüüüüüCruciate
3.5mm Cannulated Screw üüPartial thread Full thread üüüüüHex (2.5mm)
4.0mm Cannulated Screw üüShort (1/3 thread) Long (1/2 thread)üüüüüüHex (2.5mm)
4.5mm Cannulated Screw üüShort (1/3 thread) Full thread üüüüüüHex (3.5mm)
6.5mm Cannulated Screw üü16mm thread 32mm thread üüüüüüHex (4.0mm)
7.3mm Cannulated Screw üü16mm thread 32mm thread üüüüüüHex (4.0mm)
Cardinal Health™ Drill Bits
We offer a broad portfolio of drill bits in a variety of lengths, diameters and cannulations. Our drill bits offer multiple drill quick-coupling connections — Mini/Dental, AO Standard/Large, J-Latch — and include color-coding and measurement calibrations.
A variety of lengths, diameters and cannulations available
Made of surgical-grade 440A or 455 Stainless Steel
Includes color-coding and measurement calibrations 2-fluted and 3-fluted drill bits available Drill bits are made in the USA Compliant with industry standards and requirements
üüüüüü
Product features you want and need:
6
8
Cardinal Health™ Instrumentation
During the manufacturing
process, we have multiple
quality control checkpoints
to help ensure that our
products are manufactured
to Cardinal Health standards.
üüü
Our instrumentation is
designed for use with drill
bits, screws and plates
commonly available to
Orthopedic Surgeons.
All Cardinal Health™
Instruments are
manufactured in the
USA and Germany.
9
Biocompatability and materials
Screws
Screws are manufactured from 316L Stainless Steel
(ASTM F1381) or Ti-6Al-4V ELI Titanium Alloy (ASTM F1363).Screwdrivers
Screwdrivers are manufactured from surgical-grade 465 Stainless Steel (ASTM F8998) for strength and durability, which provides excellent tensile strength and reduction of twist during use.
All components are made from surgical-grade materials and are proven to be biocompatible. Surface finishes have been applied to help prevent corrosion.9
Products are
engineered so that interfaces function together for consistent quality.
© 2015 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Lit. No. 2ORTHO14-25706 (01/2015)
Cardinal Health
Orthopedic Solutions Waukegan, Illinois 60085
/orthopedics To place an order, please contact your Cardinal Health Sales Representative or call customer service at 800.964.5227.
1 A STM F138-13a: Standard Specification for Wrought 18Chromium – 14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants.
2 A STM F139-12: Standard Specification for Wrought 18Chromium – 14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants.
3 A STM F136-13: Standard Specification for Wrought Titanium – 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
4 T hird-party test data on file with Cardinal Health.
5 A STM F382-99 (2003) – Standard Specification and Test Method for Metallic Bone Plates.
6 A STM F543 – Standard Specification and Test Methods for Metallic Medical Bone Screws.
7 ISO 1797-1 Dentistry – Shanks for rotary instruments – Part 1: Shanks made of metals.
8 A STM F899 – 12b: Standard Specification for Wrought Stainless Steels for Surgical Instruments.9 S pecification drawings on file with Cardinal Health.
Cardinal Health ™ Orthopedic Solutions
Efficient supply chain
From the point of ordering to the point of care, and at every point in between, our supply chain expertise improves efficiency, increases productivity, and reduces costs. • No separate procurement process or additional labor • Next-day delivery*• Exceptional fill rates
• RFID capabilities to drive greater efficiency in order and inventory control
High-quality products
Begin saving on high-quality, standard products based on industry-proven and accepted designs. Leveraging a new model and reducing overhead allows us to offer high-quality products for less.• A broad portfolio of products available that includes orthopedic trauma and surgical products and accessories
• No change to clinical practice or technique • Manufactured in the United States, UK and Germany
• Stringent quality-control procedures • Quality manufacturing process: -ISO Certified
-Conforms to ASTM standards -Complies with FDA Good Manufacturing Practices
Flexible service options
Customizable service options, complete with analytics support, tailored to your facility’s needs.
Clinical and supply chain solutions
• Evaluation and implementation support • Ongoing on-site support • Product and process training • Par optimization
• Periodic on-hand inventory checks and recommended replenishment orders Data analytics
• Ongoing savings analyses and inventory optimization
• Economic alignment, consulting and administration
*Customers must place their order before 12 p.m. local time. Next-day delivery applies only to customers within the continental 48 states.。