INTRAFIX 254681

GUDID 10886705013623

FEMORAL INTRAFIX, STANDARD Includes (1) 7mm Sheath and (1) 7mm Screw 7mm-7.5mm x 23mm

DEPUY MITEK, LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 10886705013623
• NIH Device Record Key: a57d6bfd-4964-47de-b213-3a390096eb59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRAFIX
• Version Model Number: 254681
• Catalog Number: 254681
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• 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

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705013623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063577

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-02
• Device Publish Date: 2015-09-01

On-Brand Devices [INTRAFIX]

• 10886705013524: Femoral INTRAFIX Sheath Inserter 9mm - 10mm
• 10886705013517: Femoral INTRAFIX Sheath Inserter 8mm - 8.5mm
• 10886705013500: Femoral INTRAFIX Sheath Inserter 7mm - 7.5mm
• 10886705013494: Femoral INTRAFIX Sheath Trial 9mm - 10mm
• 10886705013487: Femoral INTRAFIX Sheath Trial 8mm - 8.5mm
• 10886705013470: Femoral INTRAFIX Sheath Trial 7mm - 7.5mm
• 10886705013166: INTRAFIX Family Tibial Sheath Inserter with Fixed Handle
• 10886705013159: INTRAFIX Tibial Sheath Trial with Fixed Handle
• 10886705013142: INTRAFIX Tibial Sheath Inserter with Fixed Handle
• 10886705005246: Femoral INTRAFIX Sterilization Tray
• 10886705013661: FEMORAL INTRAFIX, STANDARD Includes (1) 9mm Sheath and (1) 9mm Screw 9mm-10mm x 23mm
• 10886705013654: FEMORAL INTRAFIX, HARD Includes (1) 9mm Sheath and (1) 8mm Screw 9mm-10mm x 23mm
• 10886705013647: FEMORAL INTRAFIX, STANDARD Includes (1) 8mm Sheath and (1) 8mm Screw 8mm-8.5mm x 23mm
• 10886705013630: FEMORAL INTRAFIX, HARD Includes (1) 8mm Sheath and (1) 7mm Screw 8mm-8.5mm x 23mm
• 10886705013623: FEMORAL INTRAFIX, STANDARD Includes (1) 7mm Sheath and (1) 7mm Screw 7mm-7.5mm x 23mm
• 10886705013616: FEMORAL INTRAFIX, HARD Includes (1) 7mm Sheath and (1) 6mm Screw 7mm-7.5mm x 23mm
• 10886705013692: Femoral INTRAFIXSystem Positioner Replacement Screw
• 10886705013593: Femoral INTRAFIX Graft Positioner
• 10886705022403: INTRAFIX PEEK Tapered Screw 8-10mm x 30mm
• 10886705022380: INTRAFIX PEEK Tapered Screw 6-8mm x 30mm
• 10886705013081: INTRAFIX Tapered Screw 6-8mm x 30mm
• 10886705013074: INTRAFIX Tibial Sheath 30mm