| Primary Device ID | B1132N1AB000020 |
| NIH Device Record Key | 986332f9-66ef-48e3-8aec-c2ec5053f529 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SHOULDER INNOVATIONS TSA SYSTEM |
| Version Model Number | Anatomic Glenoid Case Base |
| Catalog Number | 2N1AB00002 |
| Company DUNS | 080404519 |
| Company Name | Shoulder Innovations, Inc. |
| 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 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com | |
| Phone | 616 294-1026 |
| matt@shoulderinnovations.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1132N1AB000020 [Primary] |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
[B1132N1AB000020]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-09 |
| Device Publish Date | 2023-09-29 |
| B1130S1GR200650 | TSA - REAMER/DRILL 20MM |
| B1132N1AC200100 | TSA - AUGMENTED GLENOID TRIAL 20MM X 10° |
| B1132N1AC200050 | TSA - AUGMENTED GLENOID TRIAL 20MM X 5° |
| B1130S1SI200080 | TSA - GLENOID TRIAL 20MM X 8MM |
| B1130S1SI200060 | TSA - GLENOID TRIAL 20MM X 6MM |
| B1130S1GG000200 | TSA - Peripheral Drill Guide 20mm |
| B1130S1GR300750 | Glenoid Reamer Assembly - 30MM |
| B1130S1GR270750 | Glenoid Reamer Assembly - 27MM |
| B1130S1GR240750 | Glenoid Reamer Assembly - 24MM |
| B1130S1GR220750 | Glenoid Reamer Assembly - 22MM |
| B1130S1GR200750 | Glenoid Reamer Assembly - 20MM |
| B1130S1GSP24750 | SP Glenoid Reamer Assembly - 24MM |
| B1130S1GSP10010 | SP 1mm Reamer Stop |
| B1130S1GSP00050 | SP Peripheral Drill 5mm |
| B1130S1GSP00010 | SP Cannulated Central Drill 6.5mm |
| B1132N1AB000020 | Instrument Case Base, Shoulder Innovations Anatomic Glenoid case base |
| B1132N1AT000030 | Instrument Case, Shoulder Innovations Humeral Tray |