AccessGUDID - DEVICE: Shoulder Innovations TSA (B1132N1AI220050)

GUDID

Device Identifier (DI) Information

Brand Name: Shoulder Innovations TSA
Version or Model: 22 mm x 5°
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2N1AI22005
Company Name: Shoulder Innovations, Inc.

Primary DI Number: B1132N1AI220050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080404519 *Terms of Use

Device Description: Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 22mm x 5°, Stainless Steel

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
36259	Shoulder glenoid fossa prosthesis, prefabricated	An implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

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: 4674ab08-01e3-4805-97c1-8e99300d1db1
Public Version Date: August 10, 2021
Public Version Number: 3
DI Record Publish Date: November 07, 2019