Foot Osteotomy Wedge System - Tyber Medical LLC

Duns Number:010968002

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More Product Details

Catalog Number

08.844.204S

Brand Name

Foot Osteotomy Wedge System

Version/Model Number

08.844.204S

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

K150394

Product Code Details

Product Code

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

24652576-05a3-410f-a7a9-a0d95a86ba71

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

March 20, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TYBER MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 440
2 A medical device with a moderate to high risk that requires special controls. 7793