Drive Rail System - SET SCREW - ORTHOPEDIATRICS CORP.

Duns Number:796416191

Device Description: SET SCREW

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More Product Details

Catalog Number

22-3601

Brand Name

Drive Rail System

Version/Model Number

22-3601

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K140822,K220809

Product Code Details

Product Code

KTT

Product Code Name

APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Device Record Status

Public Device Record Key

ab2ba04f-7751-49d9-8a58-523dba6d6402

Public Version Date

June 27, 2022

Public Version Number

1

DI Record Publish Date

June 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOPEDIATRICS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1662
2 A medical device with a moderate to high risk that requires special controls. 7273