FDA.reportPublic FDA data

Curved Lasso Guide

Primary DI
G523T1008710
Brand
Curved Lasso Guide
Company
Cc-Instruments Inc.
Model
T100871
Device description
Curved Lasso Guide
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
G523T1008710PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length146.5Millimeter

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
G523T1005220Sub-Coracoid Clip - Round 10mm, CurvedT1005222024-11-15
G523T1005310Straight Lasso GuideT1005312024-11-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QCChest Wall Innovations, Inc.HTN2026-06-01
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00850080543122PC Fix Clamp/Drill Guide BottomChest Wall Innovations, Inc.HTN2026-06-01
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00850080543146PC Fix 3.2mm Drill Dental LatchChest Wall Innovations, Inc.HTN2026-06-01
00850080543184PC Fix Implant CaddyChest Wall Innovations, Inc.HTN2026-06-01
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