CoNextions TR Tendon Repair System-Combo Kit

Basic Information

• Brand Name: CoNextions TR Tendon Repair System-Combo Kit
• Primary DI: 00861445000303
• Version / Model: FA0001
• Catalog Number: FA0001
• Company Name: CONEXTIONS MEDICAL INC
• Labeler DUNS: 063692935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-28
• Public Version: 1
• Public Version Date: 2022-05-06
• Public Version Status: New
• Public Device Record Key: e8e54a3f-9cdb-4929-b474-b6be61952a6e

Device Description

The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	878.4495	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62523	Tendon coaptation implant deployment tool	A sterile, hand-held, mechanical surgical instrument intended to be used to approximate the ends of a lacerated or ruptured tendon and to subsequently deploy a tendon coaptation implant in order to reattach the tendon ends. It is in the form of a stapler-like deployment gun with a proximal control used to deploy the distally-loaded implant. This is a single-use device.	No	Active
62522	Tendon coaptation implant	A sterile, implantable, non-bioabsorbable device intended to be used to reattach the ends of a lacerated or ruptured tendon in order to repair the tendon and restore its function. It is in the form of small suture-like wires made of metal and synthetic polymer materials, and is permanently implanted into the tendon ends with a dedicated stapler-like tool. Disposable devices intended to assist implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10861445000300	GS1	10-Pack	10	In Commercial Distribution
Primary	00861445000303	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K203855	000