Tibial Insert Trial, PS-Post, Klassic ONE - Tibial Insert Trial,PS-Post, size 3, 10mm - TOTAL JOINT ORTHOPEDICS, INC.

Duns Number:078416717

Device Description: Tibial Insert Trial,PS-Post, size 3, 10mm

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More Product Details

Catalog Number

-

Brand Name

Tibial Insert Trial, PS-Post, Klassic ONE

Version/Model Number

2254.03.010

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

-

Product Code Details

Product Code

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

de0d76b2-3801-49dc-9994-6eb275a471c9

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

October 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOTAL JOINT ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 880
2 A medical device with a moderate to high risk that requires special controls. 732