DigiFuse Cannulated Intramedullary Fusion DF2010

GUDID 00885556824795

DIGIFUSE IMPLANT 2.0MM 10 DEGREE ANGLE

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00885556824795
• NIH Device Record Key: d72f4c93-c564-46ca-8d62-c2f76dbc4a93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DigiFuse Cannulated Intramedullary Fusion
• Version Model Number: DF2010
• Catalog Number: DF2010
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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: false
• 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

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556824795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111536

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

[00885556824795]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-20
• Device Publish Date: 2023-02-10

On-Brand Devices [DigiFuse Cannulated Intramedullary Fusion]

• 00885556835012: DIGIFUSE SCREW PICKUP FORCEPS
• 00885556824894: DIGIFUSE GUIDE WIRE SMOOTH .80 X 70MM
• 00885556824887: GUIDE WIRE SMOOTH .82 X 90MM (DOUBLE POINT)
• 00885556824870: STERILIZATION TRAY LID. DIGIFUSE. DF2000S SLOTS
• 00885556824863: STERILIZATION TRAY. DIGIFUSE. DF2000S SLOTS
• 00885556824856: DIGIFUSE BROACH
• 00885556824849: 10 DEGREE DIGIFUSE DRIVER SHAFT
• 00885556824832: 0 DEGREE DIGIFUSE DRIVER SHAFT
• 00885556824825: DIGIFUSE IMPLANT 2.5MM 10 DEGREE ANGLE
• 00885556824818: DIGIFUSE IMPLANT 2.5MM 0 DEGREE ANGLE
• 00885556824801: DIGIFUSE IMPLANT 2.0MM 10 DEGREE ANGLE SHORT
• 00885556824795: DIGIFUSE IMPLANT 2.0MM 10 DEGREE ANGLE
• 00885556824788: DIGIFUSE IMPLANT 2.0MM 0 DEGREE ANGLE SHORT
• 00885556824771: DIGIFUSE IMPLANT 2.0MM 0 DEGREE ANGLE MINI BLADE
• 00885556824764: DIGIFUSE IMPLANT 2.0MM 0 DEGREE ANGLE
• 00885556824757: DIGIFUSE RATCHET HANDLE