FDA.reportPublic FDA data

The Better Bunion

Primary DI
G2710121280230
Brand
The Better Bunion
Company
Mios Marketing, LLC
Model
Lapidus
Device description
Dorsal Lapidus Guide, Left, 28mm x 23mm
Published
2022-08-19
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
PBKNon-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBKNon-Variola Orthopoxvirus Real-Time Pcr Primer And Probe SetMicrobiology2

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
G2710121280230PrimaryHIBCC0

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.

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