HammerFiX

GUDID 00842078100059

Medium PEEK Hammertoe Implant

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00842078100059
• NIH Device Record Key: 526080a4-e12f-4df8-931e-dbf44a0d44e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HammerFiX
• Version Model Number: 132-34015-S
• Company DUNS: 832720358
• Company Name: EXTREMITY MEDICAL, 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00842078100059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133636

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-01

On-Brand Devices [HammerFiX]

• 00842078100066: Large PEEK Hammertoe Implant
• 00842078100059: Medium PEEK Hammertoe Implant
• 00842078100042: Small PEEK Hammertoe Implant