Shoulder Innovations TSA - Shoulder Innovations - TSA. Glenoid Circular In - Shoulder Innovations, Inc.

Duns Number:080404519

Device Description: Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 30mm x 6mm. UHMWPE.

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More Product Details

Catalog Number

0S0CI30006

Brand Name

Shoulder Innovations TSA

Version/Model Number

30 mm x 6 mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K102670,K110905,K111596

Product Code Details

Product Code

HSD

Product Code Name

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Device Record Status

Public Device Record Key

5558161e-84f5-4099-b0f5-51c463409e5b

Public Version Date

August 10, 2021

Public Version Number

5

DI Record Publish Date

December 05, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHOULDER INNOVATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 443