HammerTech™ Fixation System HT-60-1212-S

GUDID 00852164007209

Reaming Implant Kit 12mm

FUSION ORTHOPEDICS, LLC

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

• Primary Device ID: 00852164007209
• NIH Device Record Key: aea3d22a-12bc-414c-a7c3-6951e9a2cc2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HammerTech™ Fixation System
• Version Model Number: HT-60-1212-S
• Catalog Number: HT-60-1212-S
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, 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: true
• 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	00852164007209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161449

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: 2017-11-02

On-Brand Devices [HammerTech™ Fixation System]

• 00852164007209: Reaming Implant Kit 12mm
• 00852164007193: Reaming Implant Kit 10mm
• 00852164007186: Reaming Implant Kit 8mm
• 00852164007179: Large PIP Implant Single
• 00852164007162: Medium PIP Implant Single
• 00852164007155: Small PIP Implant Single
• 00852164007148: Extra Small PIP Implant Single