FDA.reportPublic FDA data

Coronet

Primary DI
00861445000334
Brand
Coronet
Company
CONEXTIONS MEDICAL INC
Model
FA01025
Catalog number
FA01025
Device description
The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used tofixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissuewasher interconnected via a continuous loop of suture. The implant comes pre-assembled toan inserter, which facilitates concurrent placement of the anchor and soft tissue washer. Adrill bit is provided to allow for the creation of a properly sized pilot hole in the boneimplantation site.
Published
2020-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTNWasher, Bolt Nut
HWCScrew, Fixation, Bone
JDRStaple, Fixation, Bone
KGSRetention Device, Suture
MAIFastener, Fixation, Biodegradable, Soft Tissue
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDRStaple, Fixation, BoneOrthopedic2
KGSRetention Device, SutureGeneral, Plastic Surgery1
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200028000Coronet Soft Tissue Fixation SystemConextions Medical2020-03-04MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10861445000331PackageGS110In Commercial Distribution
00861445000334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086144500033110861445000331
00861445000334008614450003348614450003340861445000334

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

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
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
10861445000324CoNextions TR Tendon Repair System-Implant MechanismFA0004FA00042022-04-28
10861445000331CoronetFA01025FA010252020-06-30

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