Catalog Number

135-5118

Brand Name

BioPoly® Great Toe Hemiarthroplasty Implant

Version/Model Number

135-5118

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

K203634

Product Code

KWD

Product Code Name

Prosthesis, Toe, Hemi-, Phalangeal

Public Device Record Key

9236d47b-7e54-4e5c-9ace-cd14e5812d81

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

February 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-