Coronet FA01025

GUDID 10861445000331

The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissue washer interconnected via a continuous loop of suture. The implant comes pre-assembled to an inserter, which facilitates concurrent placement of the anchor and soft tissue washer. A drill bit is provided to allow for the creation of a properly sized pilot hole in the bone implantation site.

CONEXTIONS MEDICAL INC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10861445000331
• NIH Device Record Key: e1dd5b2d-28de-4795-8538-877b9428bbc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coronet
• Version Model Number: FA01025
• Catalog Number: FA01025
• Company DUNS: 063692935
• Company Name: CONEXTIONS MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com
• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com
• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com
• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com
• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com
• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com
• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com
• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com
• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com
• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com
• Phone: (385) 351-1461
• Email: customerservice@conextionsmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861445000334 [Primary]
GS1	10861445000331 [Package]; Contains: 00861445000334; Package: 10-Pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200028

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: 2020-07-08
• Device Publish Date: 2020-06-30

Devices Manufactured by CONEXTIONS MEDICAL INC

• 10861445000300 - CoNextions TR Tendon Repair System-Combo Kit: 2022-05-06 The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anc
• 10861445000317 - CoNextions TR Tendon Repair System-Deployment Mechanism: 2022-05-06 The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anc
• 10861445000324 - CoNextions TR Tendon Repair System-Implant Mechanism: 2022-05-06 The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anc
• 10861445000331 - Coronet: 2020-07-08The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissue washer interconnected via a continuous loop of suture. The implant comes pre-assembled to an inserter, which facilitates concurrent placement of the anchor and soft tissue washer. A drill bit is provided to allow for the creation of a properly sized pilot hole in the bone implantation site.
• 10861445000331 - Coronet: 2020-07-08 The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to ti