| Primary Device ID | B1132R2HR350000 |
| NIH Device Record Key | 67e87519-737e-4160-abe7-2cdd08b874af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Innovations Inset Reverse Total Shoulder |
| Version Model Number | RSA Humeral Convex Reamer |
| Catalog Number | 2R2HR35000 |
| 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 | B1132R2HR350000 [Primary] |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
[B1132R2HR350000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-06 |
| Device Publish Date | 2021-08-29 |
| B1132R1P1203390 | Shoulder Innovations Inset Reverse Total Shoulder - Offset Humeral Bearing - 39mm Diameter, +3 m |
| B1132R1P1203360 | Shoulder Innovations Inset Reverse Total Shoulder - Offset Humeral Bearing - 36mm Diameter, +3 m |
| B1132R1P1203330 | Shoulder Innovations Inset Reverse Total Shoulder - Offset Humeral Bearing - 33mm Diameter, +3 m |
| B1132R1P1000390 | Shoulder Innovations Inset Reverse Total Shoulder - Neutral Humeral Bearing - 39mm Diameter, 0 m |
| B1132R1P1000360 | Shoulder Innovations Inset Reverse Total Shoulder - Neutral Humeral Bearing - 36mm Diameter, 0 m |
| B1132R1P1000330 | Shoulder Innovations Inset Reverse Total Shoulder - Neutral Humeral Bearing - 33mm Diameter, 0 m |
| B1132R1M3806010 | Shoulder Innovations Inset Reverse Total Shoulder - Humeral Tray. 38mm x 6mm. |
| B1132R1M3800010 | Shoulder Innovations Inset Reverse Total Shoulder - Humeral Tray. 38mm x 0mm. Titanium |
| B1132R1GSC00420 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 42mm x 0mm x 0mm. |
| B1132R1GSC00390 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 39mm x 0mm x 0mm. |
| B1132R1GSC00360 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x 0mm. |
| B1132R1GSC00330 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 33mm x 0mm x 0mm. |
| B1132R1GLC06420 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 42mm x 0mm x +63mm. |
| B1132R1GLC06390 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 39mm x 0mm x +6mm. |
| B1132R1GLC06360 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x +6mm. |
| B1132R1GLC03420 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 42mm x 0mm x +3mm. |
| B1132R1GLC03390 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 39mm x 0mm x +3mm. |
| B1132R1GLC03360 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x +3mm. |
| B1132R1GLC03330 | Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 33mm x 0mm x +3mm. |
| B1132R1R2715250 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 15 degree |
| B1132R1R2715150 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 15 degree |
| B1132R1R2710250 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 10 degree |
| B1132R1R2710150 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 10 degree |
| B1132R1R2705250 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 5 degree, |
| B1132R1R2705150 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 5 degree, |
| B1132R1R2700250 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 0 degree, |
| B1132R1R2700150 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 0 degree, |
| B1132R1R2415250 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 15 degree |
| B1132R1R2415150 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 15 degree |
| B1132R1R2410250 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 10 degree |
| B1132R1R2410150 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 10 degree |
| B1132R1R2405250 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 5 degree, |
| B1132R1R2405150 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 5 degree, |
| B1132R1R2400250 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 0 degree, |
| B1132R1R2400150 | Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 0 degree, |
| B1132R1P1505390 | Shoulder Innovations Inset Reverse Total Shoulder - Face Changing Humeral Bearing - 39mm Diamete |
| B1132R1P1505360 | Shoulder Innovations Inset Reverse Total Shoulder - Face Changing Humeral Bearing - 36mm Diamete |
| B1132R1P1505330 | Shoulder Innovations Inset Reverse Total Shoulder - Face Changing Humeral Bearing - 33mm Diamete |
| B1132R1GN516420 | Shoulder Innovations Inset Reverse Total Shoulder - RSA Baseplate Set Screw Locking Nut (Long) |
| B1132R1GN516410 | Shoulder Innovations Inset Reverse Total Shoulder - RSA Locking Nut/Set Screw (Medium) |
| B1132R1GB407260 | Shoulder Innovations Inset Reverse Total Shoulder - Glenosphere Locking Bolt - Medium/Long |
| B1132R1GB407200 | Shoulder Innovations Inset Reverse Total Shoulder - Glenosphere Locking Bolt STD-ECC |
| B1132R2HR350020 | Shoulder Innovations Inset Reverse Total Shoulder - RSA Humeral Reamer Guide Post |
| B1132R2HR350000 | Shoulder Innovations Inset Reverse Total Shoulder - RSA Humeral Convex Reamer |
| B1132R2HI000300 | Shoulder Innovations Inset Reverse Total Shoulder - RSA Offset Twistlock Base Assembly |
| B1132R2HI000200 | Shoulder Innovations Inset Reverse Total Shoulder - RSA Offset Twistlock T-Handle Assembly |
| B1132R2HC100030 | Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Caddy Lid |
| B1132R2HC100020 | Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Caddy |
| B1132R2HC100010 | Shoulder Innovations Inset Reverse Total Shoulder - RSA Tray |
| B1132R2HC100000 | Shoulder Innovations Inset Reverse Total Shoulder - RSA Case Base |