Integra® Total Foot System" - The Integra Total Foot System is a system - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Integra Total Foot System is a system containing bone plates and screws designed for u The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. . The fore foot and mid foot plates include open wedge plates, universal forefoot plates, MPJ fusion plates, and tarsalis plates. Also included are 2.7mm locking screws.

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More Product Details

Catalog Number

FFMFOOTIMP

Brand Name

Integra® Total Foot System"

Version/Model Number

FFMFOOTIMP

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)

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

28f82d8c-8911-4ca6-af41-d3c1b5d9331d

Public Version Date

July 16, 2020

Public Version Number

4

DI Record Publish Date

September 22, 2015

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