DynaClip Bone Fixation System, Delta, 28mm x 16mm x 14mm x 12mm

GUDID M970300010281614120

Medshape, Inc.

Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: M970300010281614120
• NIH Device Record Key: 72944d92-b8b7-40ee-a75a-76783b9f6e9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaClip Bone Fixation System, Delta, 28mm x 16mm x 14mm x 12mm
• Version Model Number: 3000-10-28161412
• 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	M970300010281614120 [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

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

Devices Manufactured by Medshape, Inc.

• M97031000000200 - Removal Driver, DynaFuse: 2024-04-09
• M97031000100050 - DynaFuse 5mm Drill: 2024-04-09
• M97031000400010 - Trajectory Wire, DynaFuse: 2024-04-09
• M97031000700010 - Parallel Pin Guide, DynaFuse: 2024-04-09
• M97031000900010 - Tissue Protector, DynaFuse: 2024-04-09
• M97031001200010 - Tube Caddy, DynaFuse: 2024-04-09
• M9703000050080 - Reusable Drill Guide Assembly, T-Shape, DynaClip, 8mm: 2023-11-14
• M9703000050100 - Reusable Drill Guide Assembly, T-Shape, DynaClip, 10mm: 2023-11-14