FDA.reportPublic FDA data

The Better Bunion

Primary DI
G2710110000060
Brand
The Better Bunion
Company
Mios Marketing, LLC
Model
Lapidus
Device description
Ring Curette
Published
2022-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
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
G2710110000060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
118723037
Device count
1
Lot or batch
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

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