DynaNail Helix, Headed, 80mm

GUDID M97032000070800

Medshape, Inc.

Arthrodesis nail, sterile

• Primary Device ID: M97032000070800
• NIH Device Record Key: 2f83fd15-239e-4acc-90f8-fba50707003e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaNail Helix, Headed, 80mm
• Version Model Number: 3200-00-7080
• 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	M97032000070800 [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: 2022-04-25
• Device Publish Date: 2022-04-15

Devices Manufactured by Medshape, Inc.

• M9701000032250 - Morphix XT: 2025-07-29 MORPHIX 2.5mm x 7mm Anchor with two USP
• M9701000032350 - Morphix XT: 2025-07-29 MORPHIX 3.5mm x 8mm Anchor with two USP
• M9701000032450 - Morphix XT: 2025-07-29 MORPHIX 4.5mm x 9mm Anchor with two USP
• M9701000041250 - Morphix XT: 2025-07-29 MORPHIX Foot and Ankle, 2.5MM
• M9701000042450 - Morphix XT: 2025-07-29 MORPHIX Foot and Ankle, 4.5MM
• M9701000042550 - Morphix XT: 2025-07-29 MORPHIX Foot and Ankle, 5.5MM
• M97012000250200 - DynaNail: 2025-07-29 HEADED SCREW, DYNANAIL, CORTICAL, 20MM
• M97012000250220 - DynaNail: 2025-07-29 HEADED SCREW, DYNANAIL, CORTICAL, 22.5MM