| Primary Device ID | B1132N1IN000480 |
| NIH Device Record Key | 4c1e4894-eede-4d3c-abb0-6b4bda71c794 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Innovations Humeral Short Stem System |
| Version Model Number | 48mm |
| Catalog Number | 2N1IN00048 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1132N1IN000480 [Primary] |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
[B1132N1IN000480]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-01 |
| Device Publish Date | 2022-05-24 |
| B1132N1IT100000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Multi-Use T-handle. |
| B1132N1IN000560 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Ring Guide |
| B1132N1IN000520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Ring Guide. |
| B1132N1IN000480 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Ring Guide |
| B1132N1IN000440 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Ring Guide. |
| B1132N1IN000400 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Ring Guide. |
| B1132N2SN062801 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 28mm x 6mm. |
| B1132N1IM000100 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Impaction Stand Assembly |
| B1132N1IP004500 | Shoulder Innovations - TSA - Humeral Short Stem. Instrument. Spiked Humeral Cut Protector - 45 |
| B1132N1IP004250 | Shoulder Innovations - TSA - Humeral Short Stem. Instrument. Spiked Humeral Cut Protector - 42 |
| B1132N1IP003750 | Shoulder Innovations - TSA - Humeral Short Stem. Instrument. Spiked Humeral Cut Protector - 37 |
| B1132N1IN100560 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide |
| B1132N1IN100520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide. |
| B1132N1IN100480 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide |
| B1132N1IN100440 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide. |
| B1132N1IN100400 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide. |
| B1132N2HE140381 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 14mm High x 38mm Diamete |
| B1132N1HE140381 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Trial Head. 14mm x 38mm. |
| B1132N1IA000010 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument: K-Wire 1.6mm |
| B1132N1HG00000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument: K-Wire Guide |
| B1132N1HG000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument: K-Wire Guide |
| B1132N1HE140380 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Trial Head. 14mm x 38mm. |
| B1130S1GK000020 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument: K-Wire Guide 2.4 mm |
| B1132N2SN064400 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 44mm x 6mm. |
| B1132N2SN063800 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 38mm x 6mm. |
| B1132N2SN063200 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 32 mm x 6mm. |
| B1132N2SN062800 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 28mm x 6mm. |