| Primary Device ID | B1132N1HE150480 |
| NIH Device Record Key | 22857e4e-836c-40a0-8fa4-4b4991be9b81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Innovations Humeral Short Stem |
| Version Model Number | 15mm x 48mm |
| Catalog Number | 2N1HE15048 |
| Company DUNS | 080404519 |
| Company Name | SHOULDER INNOVATIONS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx | |
| Phone | 616-294-1026 |
| xxx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1132N1HE150480 [Primary] |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
[B1132N1HE150480]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-17 |
| Device Publish Date | 2018-12-17 |
| B1132N1AB00003 - SHOULDER INNOVATIONS TSA SYSTEM | 2021-07-08 Instrument Case Base, original Shoulder Innovations case base modified to hold InSet Plus glenoid trials |
| B1130S1GG00020 - Shoulder Innovations TSA System | 2021-05-12 |
| B1130S1GR20065 - SHOULDER INNOVATIONS TSA SYSTEM | 2021-05-12 |
| B1130S1GR22065 - SHOULDER INNOVATIONS TSA SYSTEM | 2021-05-12 |
| B1130S1SI20006 - SHOULDER INNOVATIONS TSA SYSTEM | 2021-05-12 |
| B1130S1SI20008 - SHOULDER INNOVATIONS TSA SYSTEM | 2021-05-12 |
| B1132N1AC20005 - Shoulder Innovations TSA | 2021-05-12 Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 20mm x 5°, Stainless Steel |
| B1132N1AC20010 - Shoulder Innovations TSA | 2021-05-12 Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 20mm x 10°, Stainless Steel |