| Primary Device ID | B1130S0CI220060 |
| NIH Device Record Key | 4f2b7f6b-86c6-40dd-a497-5a237926c57d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Innovations TSA |
| Version Model Number | 22 mm x 6 mm |
| Catalog Number | 0S0CI22006 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1130S0CI220060 [Primary] |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B1130S0CI220060]
Ethylene Oxide
[B1130S0CI220060]
Ethylene Oxide
[B1130S0CI220060]
Ethylene Oxide
[B1130S0CI220060]
Ethylene Oxide
[B1130S0CI220060]
Ethylene Oxide
[B1130S0CI220060]
Ethylene Oxide
[B1130S0CI220060]
Ethylene Oxide
[B1130S0CI220060]
Ethylene Oxide
[B1130S0CI220060]
Ethylene Oxide
[B1130S0CI220060]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2017-12-05 |
| B1130S0SS141300 | Shoulder Innovations TSA. Humeral Stem. 14mm x 130mm. Cobalt Chrome. |
| B1130S0SS121300 | Shoulder Innovations TSA. Humeral Stem. 12mm x130mm. Cobalt Chrome. |
| B1130S0SS101300 | Shoulder Innovations TSA. Humeral Stem. 10mm x 130mm. Cobalt Chrome. |
| B1130S0SS081300 | Shoulder Innovations TSA. Humeral Stem. 8mm x 130mm. Cobalt Chrome. |
| B1130S0SS061300 | Shoulder Innovations - TSA. Humeral Stem. 6mm x 130 mm. Cobalt Chrome. |
| B1130S0HO230520 | Shoulder Innovations TSA. Humeral Head. 23mm x 52mm. Cobalt Chrome. |
| B1130S0HO210520 | Shoulder Innovations TSA. Humeral Head. 21mm x 52mm. Cobalt Chrome. |
| B1130S0HO210460 | Shoulder Innovations TSA. Humeral Head. 21mm x 46mm. Cobalt Chrome. |
| B1130S0HO190520 | Shoulder Innovations TSA. Humeral Head. 19mm x 52mm. Cobalt Chrome. |
| B1130S0HO190460 | Shoulder Innovations TSA. Humeral Head. 19mm x 46mm. Cobalt Chrome. |
| B1130S0HO170520 | Shoulder Innovations TSA. Humeral Head. 17mm x 52mm. Cobalt Chrome. |
| B1130S0HO170460 | Shoulder Innovations TSA. Humeral Head 17mm x 46mm. Cobalt Chrome. |
| B1130S0HO170400 | Shoulder Innovations TSA. Humeral Head. 17mm x 40mm. Cobalt Chrome. |
| B1130S0HO150460 | Shoulder Innovations TSA. Humeral Head. 15 mm x 46 mm. Cobalt Chrome. |
| B1130S0HO150400 | Shoulder Innovations TSA. Humeral Head. 15 mm x 40 mm. Cobalt Chrome. |
| B1130S0CI300080 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 30 mm x 8 mm. UHMWPE. |
| B1130S0CI300060 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 30mm x 6mm. UHMWPE. |
| B1130S0CI270080 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 27mm x 8mm. UHMWPE. |
| B1130S0CI270060 | Shoulder Innovations TSA. Glenoid Circular In Line Peg. 27mm x 6mm. UHMWPE. |
| B1130S0CI240080 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 24mm x 8mm. UHMWPE. |
| B1130S0CI240060 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 24mm x 6mm. UHMWPE. |
| B1130S0CI220080 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 22mm x 8mm, UHMWPE. |
| B1130S0CI220060 | Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 22m x 6mm. UHMWPE. |
| B1132N2AI220050 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 22mm x 5°, UHMWPE |
| B1132N2AI300100 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 30mm x 10°, UHMWPE |
| B1132N2AI300050 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 30mm x 5°, UHMWPE |
| B1132N2AI270100 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 27mm x 10°, UHMWPE |
| B1132N2AI270050 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 27mm x 5°, UHMWPE |
| B1132N2AI240100 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 24mm x 10°, UHMWPE |
| B1132N2AI240050 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 24mm x 5°, UHMWPE |
| B1132N2AI220100 | Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 22mm x 10°, UHMWPE |
| B1132N1AI300100 | Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 30mm x 10°, Stainless Stee |
| B1132N1AI300050 | Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 30mm x 5°, Stainless Steel |
| B1132N1AI270100 | Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 27mm x 10°, Stainless Stee |
| B1132N1AI270050 | Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 27mm x 5°, Stainless Steel |
| B1132N1AI240100 | Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 24mm x 10°, Stainless Stee |
| B1132N1AI240050 | Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 24mm x 5°, Stainless Steel |
| B1132N1AI220100 | Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 22mm x 10°, Stainless Stee |
| B1132N1AI220050 | Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 22mm x 5°, Stainless Steel |
| B1132N1AC30010 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 30mm x 10°, Stainless Steel |
| B1132N1AC30005 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 30mm x 5°, Stainless Steel |
| B1132N1AC27010 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 27mm x 10°, Stainless Steel |
| B1132N1AC27005 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 27mm x 5°, Stainless Steel |
| B1132N1AC24010 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 24mm x 10°, Stainless Steel |
| B1132N1AC24005 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 24mm x 5°, Stainless Steel |
| B1132N1AC22010 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 22mm x 10°, Stainless Steel |
| B1132N1AC22005 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 22mm x 5°, Stainless Steel |
| B1132N1AC20010 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 20mm x 10°, Stainless Steel |
| B1132N1AC20005 | Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 20mm x 5°, Stainless Steel |