T2 1851-1424S

GUDID 07613252133230

Femoral Nail, RIGHT

Stryker Trauma GmbH

Femur nail, sterile Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail

• Primary Device ID: 07613252133230
• NIH Device Record Key: 48b1f6be-bc8c-40eb-9156-0272e2c99714
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2
• Version Model Number: 1851-1424S
• Catalog Number: 1851-1424S
• Company DUNS: 330211587
• Company Name: Stryker Trauma GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0
• Length: 240 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252133230 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101438

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [T2]

• 07613327005523: Fixation K-Wire SPI, WCH coated
• 07613327005516: Plug SPI
• 07613327005486: Trocar SPI ¿8-11
• 07613327005479: Tray Inlay SPI
• 07613327005462: Modular Handle SPI
• 07613327005431: Drill Sleeve SPI ¿8-13, PTFE coated
• 07613327005424: Drill Sleeve SPI ¿8-11, PTFE coated
• 07613327005417: Nail Insertion Sleeve, elastic SPI ¿8-13
• 07613327005400: Screwdriver, Compression SPI Hex 3,5mm
• 07613327005394: Nail Holding Screw SPI
• 07613327005387: Nail Adapter SPI
• 07613327005370: Opening Drill SPI
• 07613327003949: Trocar SPI ¿8-13
• 07613252630425: Tray Inlay SPI
• 07613252577478: Fixation K-Wire SPI, WCH coated
• 07613252212225: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252212218: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252212201: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252212195: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252212188: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252212171: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252133247: Femoral Nail, RIGHT
• 07613252133230: Femoral Nail, RIGHT
• 07613252133223: Femoral Nail, RIGHT
• 07613252133209: Femoral Nail, RIGHT
• 07613252133117: Femoral Nail, RIGHT
• 07613252133100: Femoral Nail, RIGHT
• 07613252133094: Femoral Nail, RIGHT
• 07613252133087: Femoral Nail, RIGHT
• 07613252132998: Femoral Nail, RIGHT
• 07613252132974: Femoral Nail, RIGHT
• 07613252132967: Femoral Nail, RIGHT
• 07613252132950: Femoral Nail, RIGHT
• 07613252132851: Femoral Nail, RIGHT
• 07613252132844: Femoral Nail, RIGHT
• 07613252132837: Femoral Nail, RIGHT
• 07613252132820: Femoral Nail, RIGHT
• 07613252132721: Femoral Nail, RIGHT
• 07613252132714: Femoral Nail, RIGHT
• 07613252132707: Femoral Nail, RIGHT
• 07613252132684: Femoral Nail, RIGHT
• 07613252132592: Femoral Nail, RIGHT
• 07613252132585: Femoral Nail, RIGHT
• 07613252132578: Femoral Nail, RIGHT
• 07613252132554: Femoral Nail, RIGHT
• 07613252132493: Femoral Nail, RIGHT
• 07613252132479: Femoral Nail, RIGHT
• 07613252132356: Femoral Nail, LEFT
• 07613252132349: Femoral Nail, LEFT
• 07613252132332: Femoral Nail, LEFT