| Primary Device ID | B1132N2SN064401 |
| NIH Device Record Key | 0f7354c9-2bbd-4596-8d30-da30966d81f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Innovations Humeral Short Stem System |
| Version Model Number | 44mm x 6mm |
| Catalog Number | 2N2SN06440 |
| 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 | B1132N2SN064401 [Primary] |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B1132N2SN064401]
Radiation Sterilization
[B1132N2SN064401]
Radiation Sterilization
[B1132N2SN064401]
Radiation Sterilization
[B1132N2SN064401]
Radiation Sterilization
[B1132N2SN064401]
Radiation Sterilization
[B1132N2SN064401]
Radiation Sterilization
[B1132N2SN064401]
Radiation Sterilization
[B1132N2SN064401]
Radiation Sterilization
[B1132N2SN064401]
Radiation Sterilization
[B1132N2SN064401]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-03-07 |
| Device Publish Date | 2018-12-17 |
| B1132N2SN064401 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 44mm x 6mm. |
| B1132N2SN063801 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 38mm x 6mm. |
| B1132N2SN063201 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 32 mm x 6mm. |
| B1132N2HE210561 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 56mm Diamete |
| B1132N2HE210521 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 52mm Diamete |
| B1132N2HE210481 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 48mm Diamete |
| B1132N2HE210441 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 44mm Diamete |
| B1132N2HE180561 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 56mm Diamete |
| B1132N2HE180521 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 52mm Diamete |
| B1132N2HE180481 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 48mm Diamete |
| B1132N2HE180441 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 44mm Diamete |
| B1132N2HE180401 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 40mm Diamete |
| B1132N2HE150521 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 52mm Diamete |
| B1132N2HE150481 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 48mm Diamete |
| B1132N2HE150441 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 44mm Diameter |
| B1132N2HE150401 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 40mm Diamete |
| B1132N1IZ000560 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Sizer Disk. 56mm. |
| B1132N1IZ000520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Sizer Disk - 52mm |
| B1132N1IZ000480 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Sizer Disk. 48mm. |
| B1132N1IZ000440 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Sizer Disk. 44mm. |
| B1132N1IZ000400 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Sizer Disk - 40mm |
| B1132N1IV000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Version Control. |
| B1132N1IT000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Multi-Use Tool. |
| B1132N1IS000010 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Screwdriver. |
| B1132N1IR00000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Stem Drill |
| B1132N1IP000560 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Cut Protector - 56 |
| B1132N1IP000520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Cut Protector - 52 |
| B1132N1IP000480 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Cut Protector - 48 |
| B1132N1IP000440 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Cut Protector - 44m |
| B1132N1IP000400 | Shoulder Innovations - TSA - Humeral Short Stem. Instrument. Humeral Cut Protector - 40 mm. |
| B1132N1IM000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Impaction Stand |
| B1132N1IJ000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Broach Impactor Handle. |
| B1132N1IH000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Impactor |
| B1132N1IG000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Inspection Gauge. |
| B1132N1IF000610 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Calcar Planar - 61mm |
| B1132N1IF000530 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Calcar Planar - 53mm. |
| B1132N1IF000450 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Calcar Planar- 45mm. |
| B1132N1IE000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Gauge. |
| B1132N1ID000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Distractor |
| B1132N1IA000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument - 2D Humeral Cut Guide |
| B1132N1HI000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial Insert. |
| B1132N1HE210560 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm |
| B1132N1HE210520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm |
| B1132N1HE210480 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mmx |
| B1132N1HE210440 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm |
| B1132N1HE180520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 18mm |
| B1132N1HE180480 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Trial Head. 18mm |
| B1132N1HE180440 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 18mm x |
| B1132N1HE180400 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 18mm x |
| B1132N1HE150520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 15mm |