DynaNail Helix, Headless, 55mm

GUDID M97032000170550

Medshape, Inc.

Arthrodesis nail, sterile

• Primary Device ID: M97032000170550
• NIH Device Record Key: 1eed9494-ebdb-47ed-b9ea-baff63f4f281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaNail Helix, Headless, 55mm
• Version Model Number: 3200-01-7055
• 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	M97032000170550 [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.

• M97015000009200 - Eclipse: 2025-08-19 ECLIPSE, 9MM X 20MM
• M97029002402500 - DynaNail Mini: 2025-08-14 CONNECTION SCREW, M2.5, DYNANAIL MINI
• M97015000400000 - Eclipse: 2025-08-13 Tendon Spear, ExoShape Tenodesis
• M97022001100010 - DynaNail: 2025-08-13 Inline Ratchet Driver, DynaNail
• M97022002900000 - DynaNail: 2025-08-13 FRAME ASSEMBLY, CF, DYNANAIL
• M97022010900400 - DynaNail: 2025-08-13 Drill, 4.0mm x 15cm, Dynanail
• M9702300010500 - Eclipse: 2025-08-13 Acorn Reamer, 5.00mm
• M9702300010550 - Eclipse: 2025-08-13 Acorn Reamer, 5.50mm