FDA.reportPublic FDA data

Intelliguides

Primary DI
G2710820320080
Brand
Intelliguides
Company
Mios Marketing, LLC
Model
Intellishift
Catalog number
08-2032-008
Device description
Zadik Calcaneal Guide, 32mm x 8°
Published
2023-06-01
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
G2710820320080PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle8degree
Length32Millimeter

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
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
G2710820320160IntelliguidesIntellishift08-2032-0162023-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118155580UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155597UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155603UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155610UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155627UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155634UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155641UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155658UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155665UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155672UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155689UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155696UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155702UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155719UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155726UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155733UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155740UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155757UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
00888118155764UPPER EXTREMITY, IPSKLS-Martin L.P.PBF2026-10-21
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