Construct® Ankle Fusion Plate System - The Construct Ankle Fusion Plate System consists - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Construct Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral The Construct Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral tibia-talus-calcaneus arthrodesis plates. The plates are contoured to the peri articular anatomy and have tapered threaded holes which accept compression or locking threaded screws with a major thread diameter of 4.5 or 6.5mm. All plates and screws are manufactured from stainless steel or titanium. The system is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions, and replantation of small bones in the foot and ankle. Instruments are provided.

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More Product Details

Catalog Number

AFPIMP

Brand Name

Construct® Ankle Fusion Plate System

Version/Model Number

AFPIMP

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

K100176

Product Code Details

Product Code

HRS

Product Code Name

PLATE, FIXATION, BONE

Device Record Status

Public Device Record Key

aba859c0-6180-415a-bdb8-3f124d549902

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