FDA.reportPublic FDA data

CoNextions TR Tendon Repair System-Implant Mechanism

Primary DI
10861445000324
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 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.
Published
2022-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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 implant deployment toolA 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
063692935
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861445000327CoNextions TR Tendon Repair System-Implant MechanismFA0004FA00042022-04-28
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
00861445000334CoronetFA01025FA010252020-06-30
10861445000331CoronetFA01025FA010252020-06-30

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