TITAN™ - The Non-cannulated Glenoid Reamer is used to - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Non-cannulated Glenoid Reamer is used to compress and/or remove bone to create a cavit The Non-cannulated Glenoid Reamer is used to compress and/or remove bone to create a cavity of proper shape and size for the implant. 

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More Product Details

Catalog Number

-

Brand Name

TITAN™

Version/Model Number

RMR-0926-03N

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

HTO

Product Code Name

REAMER

Device Record Status

Public Device Record Key

1a995850-e497-4170-bb8a-f4abe8dde21e

Public Version Date

July 23, 2020

Public Version Number

3

DI Record Publish Date

May 19, 2016

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