DynaNail Helix, Headless, 65mm

GUDID M97032000170650

Medshape, Inc.

Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail, sterile Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length

• Primary Device ID: M97032000170650
• NIH Device Record Key: b4b225c2-e78c-4a6c-9b75-006538fa5719
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaNail Helix, Headless, 65mm
• Version Model Number: 3200-01-7065
• Company DUNS: 601306413
• Company Name: Medshape, 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: false
• 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	M97032000170650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203595

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: 2022-04-26
• Device Publish Date: 2022-04-18

Devices Manufactured by Medshape, Inc.

• 00810028395848 - Half Pin - 3mm x 100mm with 25mm Thread: 2024-07-02
• 00810028397712 - Rail T Handle (Red) Long with 9/64 Tool Shaft: 2024-07-02
• 00810028395886 - Collet - 3mm - Black: 2024-06-10
• 00810028395909 - Collet - 4mm - Red: 2024-06-10
• 00810028395923 - Collet - 6mm - Green: 2024-06-10
• 00810028395947 - Collet - 6mm - Green: 2024-06-10
• 00810028395961 - Half Pin - 3mm x 100mm with 25mm Thread: 2024-06-10
• 00810028396012 - 4.0 x 300mm Transfixing Pin: 2024-06-10