AccessGUDID - DEVICE: Shoulder Innovations Humeral Short Stem System (B1132N2HE210500)

GUDID

Device Identifier (DI) Information

Brand Name: Shoulder Innovations Humeral Short Stem System
Version or Model: 21mm x 50mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2N2HE21050
Company Name: Shoulder Innovations, Inc.

Primary DI Number: B1132N2HE210500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080404519 *Terms of Use

Device Description: Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 50mm Diameter R26mm Articulation.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35670	Total shoulder prosthesis	A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102670	000
K110905	000
K111596	000
K173824	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6806ece8-689d-489e-a759-76ca986cd6cb
Public Version Date: August 10, 2021
Public Version Number: 2
DI Record Publish Date: November 23, 2020