FDA.reportPublic FDA data

Clavicle Clip - 20mm

Primary DI
G523T1005161
Brand
Clavicle Clip - 20mm
Company
Cc-Instruments Inc.
Model
T100516
Device description
Clavicle Clip - 20mm
Published
2024-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
G523T1005161PackageHIBCC10In Commercial Distribution
G523T1005160PrimaryHIBCC0

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
Length20Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119059465
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
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
G523T1005220Sub-Coracoid Clip - Round 10mm, CurvedT1005222024-11-15
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
G523T1005251Sub-Coracoid Clip - Round 12mm, CurvedT1005252024-11-15
G523T1005261Sub-Coracoid Clip - Small, Rectangle, CurvedT1005262024-11-15

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Primary DI, Brand, Company table
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00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
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