MD3T™ Multi-Directional Tibial Tubercle Transfer System - Outrigger Saw Guide, Slotted, B - Kinamed, Inc.

Duns Number:184896645

Device Description: Outrigger Saw Guide, Slotted, B

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More Product Details

Catalog Number

23-800-2011

Brand Name

MD3T™ Multi-Directional Tibial Tubercle Transfer System

Version/Model Number

23-800-2011

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

-

Prescription Use (Rx)

-

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

3b347ead-635d-4e78-ad32-73b6a9d0dffd

Public Version Date

October 11, 2022

Public Version Number

1

DI Record Publish Date

October 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KINAMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 131