HammerTech CD-HT-5550-S

GUDID 00852164007551

Ti Implant Instrument Kit Large

FUSION ORTHOPEDICS, LLC

Joint prosthesis implantation kit, single-use

• Primary Device ID: 00852164007551
• NIH Device Record Key: 1d878102-bf1f-416e-a29a-d2ca3d4b74b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HammerTech
• Version Model Number: CD-HT-5550-S
• Catalog Number: CD-HT-5550-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: 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	00852164007551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182684

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-07
• Device Publish Date: 2019-04-29

On-Brand Devices [HammerTech ]

• 00852164007032: Large PIP Implant
• 00852164007025: Medium PIP Implant
• 00852164007018: Small PIP Implant
• 00852164007001: Extra Small PIP Implant
• 00852164007407: PEEK Implant Large
• 00852164007391: PEEK Implant Medium
• 00852164007384: PEEK Implant Small
• 00852164007377: PEEK Implant Extra Small
• 00852164007360: PEEK Implant Petite
• 00852164007339: Ti Implant 10° Angled Large
• 00852164007322: Ti Implant 10° Angled Medium
• 00852164007315: Ti Implant 10° Angled Small
• 00852164007308: Ti Implant 10° Angled Extra Small
• 00852164007292: Ti Implant 10° Angled Petite
• 00852164007278: Ti Implant Medium
• 00852164007261: Ti Implant Small
• 00852164007254: Ti Implant Extra Small
• 00852164007247: Ti Implant Petite
• 00819034027460: HT Ti Angled Driver Petite
• 00819034027453: HT Ti Standard Driver Medium
• 00819034027446: HT Ti Standard Driver Large
• 00819034027439: HT Ti Standard Driver Small
• 00819034027248: HT PEEK Removal Tool
• 00819034027231: HT PEEK Sizer Wheel
• 00819034027187: HT PEEK Calibrated Drill Large
• 00819034027170: HT PEEK Calibrated Drill Medium
• 00819034027163: HT PEEK Calibrated Drill Small
• 00819034027156: HT PEEK Calibrated Drill Extra Small
• 00819034027149: HT PEEK Calibrated Drill Petite
• 00819034027132: HT PEEK Driver Large
• 00819034027125: HT PEEK Driver Medium
• 00819034027118: HT PEEK Driver Small
• 00819034027101: HT PEEK Driver Extra Small
• 00819034027095: HT PEEK Driver Petite
• 00819034024872: HT Ti Standard Driver Extra Small
• 00819034024841: HT Ti Standard Driver Petite
• 00852164007988: Cup and Cone Reamer Implant System 12mm
• 00852164007971: Cup and Cone Reamer Implant System 10mm
• 00852164007964: Cup and Cone Reamer Implant System 8mm
• 00852164007957: Removal Tool PEEK
• 00852164007940: HT Ti Sizer Wheel Titanium
• 00852164007933: HT Ti Sizer Wheel Titanium
• 00852164007926: HT Awl (Single)
• 00852164007919: PEEK Implant Instrument Kit Large
• 00852164007902: HT Sizer Wheel PEEK
• 00852164007896: PEEK Implant Instrument Kit Medium
• 00852164007889: PEEK Implant Instrument Kit Small
• 00852164007872: PEEK Implant Instrument Kit Extra Small
• 00852164007865: PEEK Implant Instrument Kit Petite
• 00852164007858: Large PEEK Implant (Single)