Integra® External Fixation System - The strut is an adjustable component designed to - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The strut is an adjustable component designed to facilitate building and maintaining frame The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features an unlocked mode, where large adjustments may be made to the component’s vertical translation. It also features one distal end which is designed to enable construction of frames with offset rings or different diameter rings. The tightened mode allows for fine adjustments in vertical translation; this enables surgeons to conveniently apply compression and distraction to the frame, both intra-operatively and post-operatively. The fully locked mode restricts translation and angular movement creating a rigid construct.

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More Product Details

Catalog Number

12225210

Brand Name

Integra® External Fixation System

Version/Model Number

12225210

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

K140463

Product Code Details

Product Code

KTT

Product Code Name

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

Device Record Status

Public Device Record Key

1cc8c922-2964-4cc0-a481-6c327a1ae278

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASCENSION ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1909
2 A medical device with a moderate to high risk that requires special controls. 1404
3 A medical device with high risk that requires premarket approval 12
U Unclassified 15