Integra Stainless Headed Compression Screw System - The Headed Compression Screw System contains - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Headed Compression Screw System contains compression screws used with the Ankle Fusion The Headed Compression Screw System contains compression screws used with the Ankle Fusion Plating System. This set includes screws with diameter 4.0mm or 4.5mm

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More Product Details

Catalog Number

HEADMIDSET

Brand Name

Integra Stainless Headed Compression Screw System

Version/Model Number

HEADMIDSET

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

2b98ad33-6127-4921-aa99-9ea5680c55ac

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