Integra® Total Foot System - The Integra Total Foot System interpositioning - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Integra Total Foot System interpositioning plate is used to space apart two bones or a The Integra Total Foot System interpositioning plate is used to space apart two bones or a joint. The plate is anatomically T-shaped with increased width and stem depth for ease of insertion and less intraoperative contouring required.

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More Product Details

Catalog Number

2802110

Brand Name

Integra® Total Foot System

Version/Model Number

2802110

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

K100502,K123000

Product Code Details

Product Code

HRS

Product Code Name

PLATE, FIXATION, BONE

Device Record Status

Public Device Record Key

811790a1-11d6-42ea-be7a-917513d3aef2

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