Integra® Titanium Bone Wedge System - The Integra® Titanium Bone Wedges are intended to - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for b The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fracturesor osteotomies in the ankle and foot

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More Product Details

Catalog Number

TBW-1006-LG10

Brand Name

Integra® Titanium Bone Wedge System

Version/Model Number

TBW-1006-LG10

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

K131360

Product Code Details

Product Code

HRS

Product Code Name

PLATE, FIXATION, BONE

Device Record Status

Public Device Record Key

af874e30-c773-4995-a412-24f7ae6020aa

Public Version Date

June 08, 2021

Public Version Number

5

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