Catalog Number

-

Brand Name

The Better Bunion

Version/Model Number

Lapidus

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2099

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K220717

Product Code

PBF

Product Code Name

Orthopaedic Surgical Planning And Instrument Guides

Public Device Record Key

b16007f1-a90f-4695-937c-ce57dfb53578

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-