CoNextions TR Tendon Repair System-Implant Mechanism FA0004

GUDID 10861445000324

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.

CONEXTIONS MEDICAL INC

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Primary Device ID10861445000324
NIH Device Record Key26603f1a-e9e2-427d-9d26-ee09675af79e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoNextions TR Tendon Repair System-Implant Mechanism
Version Model NumberFA0004
Catalog NumberFA0004
Company DUNS063692935
Company NameCONEXTIONS MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com
Phone(385) 351-1461
Emailcustomerservice@conextionsmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100861445000327 [Primary]
GS110861445000324 [Package]
Contains: 00861445000327
Package: 1 [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-06
Device Publish Date2022-04-28

Devices Manufactured by CONEXTIONS MEDICAL INC

10861445000300 - CoNextions TR Tendon Repair System-Combo Kit2022-05-06 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 Mechanism2022-05-06 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 Mechanism2022-05-06The 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.
10861445000324 - CoNextions TR Tendon Repair System-Implant Mechanism2022-05-06 The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anc
10861445000331 - Coronet2020-07-08 The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to ti

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