Catalog Number

2R2HI00020

Brand Name

Shoulder Innovations Inset Reverse Total Shoulder

Version/Model Number

RSA Offset Twistlock T-Handle Assembly

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

MBF

Product Code Name

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Public Device Record Key

79ad40ce-c663-4ced-99c5-e73c35035c74

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-