FDA.reportPublic FDA data

Sub-Coracoid Clip - Round 10mm, Curved

Primary DI
G523T1005220
Brand
Sub-Coracoid Clip - Round 10mm, Curved
Company
Cc-Instruments Inc.
Model
T100522
Device description
Sub-Coracoid Clip - Round 10mm, Curved
Published
2024-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTNWasher, Bolt Nut

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232780000CC-Clip® Implant SystemCc-Instruments, Inc.2023-12-18HTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G523T1005221PackageHIBCC10In Commercial Distribution
G523T1005220PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Acromioclavicular joint stabilization implantA sterile implantable device intended to be used to approximate/stabilize the acromioclavicular joint to facilitate healing of a disrupted coracoclavicular ligament (i.e., the device is not intended to replace the damaged ligament). It is in the form of a cord with a loop for attachment to the coracoid process at one end, with a component for fixation to the clavicle (e.g., screw) at the other end. It may be implanted arthroscopically or during open surgery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119059465
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
G523T1004680Sub-Coracoid Clip - Round 10mmT1004682024-11-15
G523T1004770Sub-Coracoid Clip - Small, RectangleT1004772024-11-15
G523T1005150Clavicle Clip - 16mmT1005152024-11-15
G523T1005160Clavicle Clip - 20mmT1005162024-11-15
G523T1005250Sub-Coracoid Clip - Round 12mm, CurvedT1005252024-11-15
G523T1005260Sub-Coracoid Clip - Small, Rectangle, CurvedT1005262024-11-15
G523T1005200Sub-Coracoid Clip - Round 12mmT1005202024-11-15
G523T1005310Straight Lasso GuideT1005312024-11-15
G523T1008710Curved Lasso GuideT1008712024-11-15
G523T1004681Sub-Coracoid Clip - Round 10mmT1004682024-11-15
G523T1004771Sub-Coracoid Clip - Small, RectangleT1004772024-11-15
G523T1005151Clavicle Clip - 16mmT1005152024-11-15
G523T1005161Clavicle Clip - 20mmT1005162024-11-15
G523T1005251Sub-Coracoid Clip - Round 12mm, CurvedT1005252024-11-15
G523T1005261Sub-Coracoid Clip - Small, Rectangle, CurvedT1005262024-11-15

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