FDA.reportPublic FDA data

Intelliguides

Primary DI
G2710300260180
Brand
Intelliguides
Company
Mios Marketing, LLC
Model
Intellifuse
Catalog number
03-0026-018
Device description
Tibial Osteotmy Guide, 26mm x 18mm
Published
2022-11-01
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
G2710300260180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Colonic bougieA cylindrical, rod-like, manual surgical instrument intended to be inserted into the colon to explore/assess the colonic lumen, relieve colonic spasms, or dilate strictures during open-surgery procedures. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small, bulbous tip; it may be hollow for the passing of other slender devices through it. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth18Millimeter
Length26Millimeter

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
00688346003918Fine TTOLaboratoires Bodycad IncPBF2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00885556925379CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
00885556925386CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
054005500102173D-CUT3D-SidePBF2026-04-28
054005501506163D-CUT3D-SidePBF2026-04-28
054005501506233D-CUT3D-SidePBF2026-04-28
054005501506303D-CUT3D-SidePBF2026-04-28
054005501506473D-CUT3D-SidePBF2026-04-28
054005501506543D-CUT3D-SidePBF2026-04-28
054005501506613D-CUT3D-SidePBF2026-04-28
00840124525542FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525559FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525566FuzeFix LargeFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525597FuzeFix LargeFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124516779FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00840124517783FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00840124525467FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00860009815780EmbedMed3D LIFEPRINTS UK LTDPBF2026-03-30
00840124521773PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521780PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521797PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521803PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521810PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521827PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521834PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521841PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02