| Primary Device ID | B1130S1HO150400 |
| NIH Device Record Key | 3d2eb0f8-2d7d-495b-81f1-9b5100511c6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SHOULDER INNOVATIONS TSA SYSTEM |
| Version Model Number | HUMERAL HEAD TRIAL 15MM X 40MM |
| Catalog Number | 0S1HO15040 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1130S1HO150400 [Primary] |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
[B1130S1HO150400]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-31 |
| Device Publish Date | 2018-06-30 |
| B1130SIGR220650 | REAMER/DRILL 22MM |
| B1130S1SS141300 | HUMERAL STEM TRIAL 14MM X 130MM |
| B1130S1SS121300 | HUMERAL STEM TRIAL 12MM X 130MM |
| B1130S1SS101300 | HUMERAL STEM TRIAL 10MM X 130MM |
| B1130S1SS081300 | HUMERAL STEM TRIAL 8MM X 130MM |
| B1130S1SS061300 | HUMERAL STEM TRIAL 6MM X 130MM |
| B1130S1IV000000 | VERSION CONTROL HANDLE |
| B1130S1IT000000 | HUMERAL MULTI PURPOSE TOOL |
| B1130S1IR000140 | CANAL REAMER 14MM |
| B1130S1IR000120 | CANAL REAMER 12MM |
| B1130S1IR000100 | CANAL REAMER 10MM |
| B1130S1IR000080 | CANAL REAMER 8MM |
| B1130S1IR000060 | CANAL REAMER 6MM |
| B1130S1II000000 | IMPACTION STAND |
| B1130S1IH000000 | IMPACTION HEAD |
| B1130S1IF000000 | T HANDLE |
| B1130S1ID000000 | HUMERAL HEAD DISTRACTOR |
| B1130S1IC000000 | INSTRUMENT CASE |
| B1130S1IB000000 | HUMERAL HEAD GAUGE |
| B1130S1IA000000 | HUMERAL HEAD CUT GUIDE |
| B1130S1HO230520 | HUMERAL HEAD TRIAL 23MM X 52MM |
| B1130S1HO210520 | HUMERAL HEAD TRIAL 21MM X 52MM |
| B1130S1HO210460 | HUMERAL HEAD TRIAL 21MM X 46MM |
| B1130S1HO190520 | HUMERAL HEAD TRIAL 19MM X 52MM |
| B1130S1HO190460 | HUMERAL HEAD TRIAL 19MM X 46MM |
| B1130S1HO170520 | HUMERAL HEAD TRIAL 17MM X 52MM |
| B1130S1HO170460 | HUMERAL HEAD TRIAL 17MM X 46MM |
| B1130S1HO170400 | HUMERAL HEAD TRIAL 17MM X 40MM |
| B1130S1HO150460 | HUMERAL HEAD TRIAL 15MM X 46MM |
| B1130S1HO150400 | HUMERAL HEAD TRIAL 15MM X 40MM |
| B1130S1GW000000 | REAMER WRENCH |
| B1130S1GT000000 | IMPLANT/TRIAL GRASPER |
| B1130S1GS000040 | Glenoid Driver Grip |
| B1130S1GR300650 | REAMER/DRILL 30MM |
| B1130S1GR270650 | REAMER/DRILL 27MM |
| B1130S1GR240650 | REAMER/DRILL 24MM |
| B1130S1GK00020 | K WIRE |
| B1130S1GG000300 | Peripherla Drill Guide 30mm |
| B1130S1GG000270 | Peripheral Drill Guide 27mm |
| B1130S1GG000240 | Peripheral Drill Guide 24mm |
| B1130S1GG000220 | Peripheral Drill Guide 22mm |
| B1130S1GG000020 | PERIPHERAL DRILL GUIDE HANDLE |
| B1130S1GD270300 | SIZER DISK 27 + 30 |
| B1130S1GD220240 | Sizer Disk 22 + 24mm |
| B1130S1GC000020 | Center Drill |
| B1130S1GC000010 | Center Drill Cannulated |
| B1130S1GB000000 | GLENOID IMPACTOR |
| B1130S1GA000000 | ANTI ROTATION PEG |
| B1130S1CI300080 | GLENOID TRIAL 30MM X 8MM |
| B1130S1CI300060 | GLENOID TRIAL 30MM X 6MM |