Intelliguides

Primary DI
G2710310240240
Brand
Intelliguides
Company
Mios Marketing, LLC
Model
Intellifuse
Catalog number
03-1024-024
Device description
Talar Osteotmy Guide, 24mm x 24mm
Published
2023-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220717000RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC2022-06-09PBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G2710310240240PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming/guiding block, single-useA sterile surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth24Millimeter
Length24Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
877-334-3668customerservice@redpointmedical3d.com

Regulatory Flags#

DUNS number
118723037
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G2710110000030The Better BunionLapidus01-1000-0032022-08-19
G2711020310100IntelliguidesCHARCOT CHAMP10-2031-0102023-07-01
G2711020310110IntelliguidesCHARCOT CHAMP10-2031-0112023-07-01
G2711020310120IntelliguidesCHARCOT CHAMP10-2031-0122023-07-01
G2711020310130IntelliguidesCHARCOT CHAMP10-2031-0132023-07-01
G2710820300150IntelliguidesIntellishift08-2030-0152023-06-01
G2710820300160IntelliguidesIntellishift08-2030-0162023-06-01
G2710820300170IntelliguidesIntellishift08-2030-0172023-06-01
G2710820300180IntelliguidesIntellishift08-2030-0182023-06-01
G2710820320050IntelliguidesIntellishift08-2032-0052023-06-01
G2710820320060IntelliguidesIntellishift08-2032-0062023-06-01
G2710820320070IntelliguidesIntellishift08-2032-0072023-06-01
G2710820320080IntelliguidesIntellishift08-2032-0082023-06-01
G2710820320090IntelliguidesIntellishift08-2032-0092023-06-01
G2710820320100IntelliguidesIntellishift08-2032-0102023-06-01
G2710820320110IntelliguidesIntellishift08-2032-0112023-06-01
G2710820320120IntelliguidesIntellishift08-2032-0122023-06-01
G2710820320130IntelliguidesIntellishift08-2032-0132023-06-01
G2710820320140IntelliguidesIntellishift08-2032-0142023-06-01
G2710820320150IntelliguidesIntellishift08-2032-0152023-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345779939NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797063NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797070NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797087NextAR Spine Platform Medacta International SAPBF2023-07-24
G2710300240140IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240180IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240190IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240200IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240210IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240220IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240230IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240250IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260170IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260180IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260190IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260200IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260210IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260220IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260230IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260240IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260250IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280170IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280180IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280190IntelliguidesMios Marketing, LLCPBF2023-01-01