DynaClip Bone Fixation System, Quattro, 18mm x 16mm x 16mm

GUDID M9703000111816160

Medshape, Inc.

Orthopaedic bone staple, non-adjustable

• Primary Device ID: M9703000111816160
• NIH Device Record Key: c9f2448d-cd72-4c05-8639-357c61b2e7aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaClip Bone Fixation System, Quattro, 18mm x 16mm x 16mm
• Version Model Number: 3000-11-181616
• 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	M9703000111816160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220812

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

[M9703000111816160]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-07
• Device Publish Date: 2022-09-16

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• M9702300010500 - Eclipse: 2025-08-13 Acorn Reamer, 5.00mm
• M9702300010550 - Eclipse: 2025-08-13 Acorn Reamer, 5.50mm