Hammerdesis™ Interphalangeal Fusion System

GUDID G079HMR116010

1.1mm K-Wire

Intelivation, LLC

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: G079HMR116010
• NIH Device Record Key: 0a352426-2e35-474b-9e78-9fe6d09efc6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hammerdesis™ Interphalangeal Fusion System
• Version Model Number: HMR-116-01
• Company DUNS: 037368183
• Company Name: Intelivation, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G079HMR116010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231147

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

[G079HMR116010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-09
• Device Publish Date: 2024-04-01

On-Brand Devices [Hammerdesis™ Interphalangeal Fusion System]

• G079HMR4565D0: HMR-4565D
• G079HMR45650: Counter Rotation Ring, Large
• G079HMR2030: Caddy
• G079HMR116020: K-Wire Tube
• G079HMR116010: 1.1mm K-Wire
• G079HMR1084565P0: Peg Reamer, Large
• G079HMR1084565H0: Hole Reamer, Large
• G079HMR1080406P0: Peg Reamer, Small
• G079HMR1080406H0: Hole Reamer, Small
• G079HMR102S0: Inserter, Forceps
• G079HMR0406D0: Recovery Dowel, Small
• G079HMR04060: Counter Rotation Ring, Small