M-Fix 7mm

GUDID 00860366001420

Surgical implant to reduce and stabilize the acromioclavicular joint.

CORACOID SOLUTIONS LLC

Acromioclavicular joint stabilization implant

• Primary Device ID: 00860366001420
• NIH Device Record Key: d1e54f43-11a4-4e38-b4bf-2349fb70fd6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-Fix 7mm
• Version Model Number: FG3007
• Company DUNS: 073670228
• Company Name: CORACOID SOLUTIONS LLC
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860366001420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153211

FDA Product Code

• HTN: Washer, Bolt Nut

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: 2018-07-19
• Device Publish Date: 2018-06-18

Devices Manufactured by CORACOID SOLUTIONS LLC

• 00860366001406 - J-Pass Suture Passer: 2020-02-06 Suture passer used for passing suture around boney structures.
• 00860366001413 - M-Fix 4mm: 2018-07-19 The M-Fix is designed to provide reduction and stabilization of the acromioclavicular joint while providing a simpler, streamlin
• 00860366001420 - M-Fix 7mm: 2018-07-19Surgical implant to reduce and stabilize the acromioclavicular joint.
• 00860366001420 - M-Fix 7mm: 2018-07-19 Surgical implant to reduce and stabilize the acromioclavicular joint.