CoNextions TR Tendon Repair System-Implant Mechanism

Primary DI
00861445000327
Brand
CoNextions TR Tendon Repair System-Implant Mechanism
Company
CONEXTIONS MEDICAL INC
Model
FA0004
Catalog number
FA0004
Device description
The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consistingof two identical stainless steel anchors implanted in either end of the injured tendon andconnected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an ImplantMechanism and with a Deployment Mechanism to facilitate placement.
Published
2022-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203855000CoNextions TR Tendon Repair SystemConextions Medical2022-04-22GAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10861445000324PackageGS110In Commercial Distribution
00861445000327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086144500032410861445000324
00861445000327008614450003278614450003270861445000327

GMDN Terms#

Term, Definition table
TermDefinition
Tendon coaptation implantA 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.

Contacts#

Phone, Email table
PhoneEmail
(385) 351-1461customerservice@conextionsmed.com

Regulatory Flags#

DUNS number
063692935
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861445000303CoNextions TR Tendon Repair System-Combo KitFA0001FA00012022-04-28
00861445000310CoNextions TR Tendon Repair System-Deployment MechanismFA0002FA00022022-04-28
10861445000300CoNextions TR Tendon Repair System-Combo KitFA0001FA00012022-04-28
10861445000317CoNextions TR Tendon Repair System-Deployment MechanismFA0002FA00022022-04-28
10861445000324CoNextions TR Tendon Repair System-Implant MechanismFA0004FA00042022-04-28
00861445000334CoronetFA01025FA010252020-06-30
10861445000331CoronetFA01025FA010252020-06-30

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