Kinos Axiom - Kinos Axiom Flat Top Talar Implant, Size 5, Left - KINOS MEDICAL INC

Duns Number:081112239

Device Description: Kinos Axiom Flat Top Talar Implant, Size 5, Left

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More Product Details

Catalog Number

-

Brand Name

Kinos Axiom

Version/Model Number

2831.0115

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K192778

Product Code Details

Product Code

HSN

Product Code Name

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Device Record Status

Public Device Record Key

f82d67fc-5fba-4adf-9f78-19aac08889a5

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KINOS MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 96