Titan™ - Integra® Total Foot SystemThe glenoid keeled - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: Integra® Total Foot SystemThe glenoid keeled punch is used to impact the bone in the gleno Integra® Total Foot SystemThe glenoid keeled punch is used to impact the bone in the glenoid fossa for proper fit of the glenoid keel trial. It can also be used to further pressurize the cement.

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More Product Details

Catalog Number

PUN-0920-062-002

Brand Name

Titan™

Version/Model Number

PN0920062002

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

-

Product Code Details

Product Code

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

e064ad73-b375-4fc7-a39f-fd4d7b6c4c9d

Public Version Date

December 29, 2020

Public Version Number

3

DI Record Publish Date

September 05, 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