| Primary Device ID | B1132L2HB000030 |
| NIH Device Record Key | 395e5dde-5c50-4697-964b-e54890ffacc9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder Innovations InSet 185 Instrument Case/Tray |
| Version Model Number | InSet 185 Instrument Case/Tray |
| Catalog Number | 2L2HB00003 |
| 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 | true |
| 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 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com | |
| Phone | 616-294-1026 |
| info@shoulderinnovations.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1132L2HB000030 [Primary] |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B1132L2HB000030]
Moist Heat or Steam Sterilization
[B1132L2HB000030]
Moist Heat or Steam Sterilization
[B1132L2HB000030]
Moist Heat or Steam Sterilization
[B1132L2HB000030]
Moist Heat or Steam Sterilization
[B1132L2HB000030]
Moist Heat or Steam Sterilization
[B1132L2HB000030]
Moist Heat or Steam Sterilization
[B1132L2HB000030]
Moist Heat or Steam Sterilization
[B1132L2HB000030]
Moist Heat or Steam Sterilization
[B1132L2HB000030]
Moist Heat or Steam Sterilization
[B1132L2HB000030]
Moist Heat or Steam Sterilization
[B1132L2HB000030]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-22 |
| Device Publish Date | 2025-12-12 |
| B1132R1NET20360 - Shoulder Innovations Inset Reverse Total Shoulder | 2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Eccentric EZ Glenosphere - 36mm Diameter x 2mm Ecc x 0mm Lat |
| B1132R1NET30390 - Shoulder Innovations Inset Reverse Total Shoulder | 2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Eccentric EZ Glenosphere - 39mm Diameter x 3mm Ecc x 0mm Lat |
| B1132R1NET40420 - Shoulder Innovations Inset Reverse Total Shoulder | 2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Eccentric EZ Glenosphere - 42mm Diameter x 4mm Ecc x 0mm Lat |
| B1132R1NLT03330 - Shoulder Innovations Inset Reverse Total Shoulder | 2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Lateralized EZ Glenosphere - 33mm Diameter x 0mm Ecc x 3mm Lat |
| B1132R1NLT03360 - Shoulder Innovations Inset Reverse Total Shoulder | 2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Lateralized EZ Glenosphere - 36mm Diameter x 0mm Ecc x 3mm Lat |
| B1132R1NLT03390 - Shoulder Innovations Inset Reverse Total Shoulder | 2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Lateralized EZ Glenosphere - 39mm Diameter x 0mm Ecc x 3mm Lat |
| B1132R1NLT03420 - Shoulder Innovations Inset Reverse Total Shoulder | 2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Lateralized EZ Glenosphere - 42mm Diameter x 0mm Ecc x 3mm Lat |
| B1132R1NLT06330 - Shoulder Innovations Inset Reverse Total Shoulder | 2026-01-27 Shoulder Innovations Inset Reverse Total Shoulder - N22 Lateralized EZ Glenosphere - 33mm Diameter x 0mm Ecc x 6mm Lat |