Acumed
Modular Shoulder Body Assy., 13mm, Right
8manufacturers in China registered for this device type
112catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Acumed LLC, United States |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K992525 |
| Record published | 2015-10-24 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2016-02-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SH-1340R-S | In distribution | |
| SH-1513-S | In distribution | |
| SH-2207 | In distribution | |
| SH-T1613 | In distribution | |
| SH-0818-SP | In distribution | |
| SH-R1717 | In distribution | |
| SH-0822-S | In distribution | |
| SH-1340L-S | In distribution | |
| SH-1024-S | In distribution | |
| SH-1713-S | In distribution | |
| SH-T0820 | In distribution | |
| SH-0820-S | In distribution | |
| SH-T1740R | In distribution | |
| SH-1413-S | In distribution | |
| SH-R1308 | In distribution | |
| SH-0713-S | In distribution | |
| SH-T1340R | In distribution | |
| SH-1013-S | In distribution | |
| SH-T1026 | In distribution | |
| SH-0826-SP | In distribution | |
| SH-R1514 | In distribution | |
| SH-1740L-S | In distribution | |
| SH-1540R-S | In distribution | |
| SH-2200L | In distribution | |
| SH-T4321 | In distribution | |
| SH-1407 | In distribution | |
| SH-T0824 | In distribution | |
| SH-T0822 | In distribution | |
| SH-1613-S | In distribution | |
| SH-T1340L | In distribution | |
| SH-T1022 | In distribution | |
| SH-1120 | In distribution | |
| SH-0826-S | In distribution | |
| SH-R1309 | In distribution | |
| SH-R1716 | In distribution | |
| SH-2007 | In distribution | |
| SH-1022-S | In distribution | |
| SH-2203 | In distribution | |
| SH-T4722 | In distribution | |
| SH-0824-S | In distribution | |
| SH-0828-SP | In distribution | |
| SH-1540L-S | In distribution | |
| SH-0824-SP | In distribution | |
| SH-R1515 | In distribution | |
| SH-2200R | In distribution | |
| SH-0913-S | In distribution | |
| SH-T4317 | In distribution | |
| SH-1200 | In distribution | |
| SH-2217 | In distribution | |
| SH-T5119 | In distribution | |
| SH-T1024 | In distribution | |
| SH-T4718 | In distribution | |
| SH-1740R-S | In distribution | |
| SH-1313-S | In distribution | |
| SH-T1020 | In distribution | |
| SH-0820-SP | In distribution | |
| SH-1026-S | In distribution | |
| SH-1018-SP | In distribution | |
| SH-1018-S | In distribution | |
| SH-R1307 | In distribution | |
| SH-1113-S | In distribution | |
| SH-1028-SP | In distribution | |
| SH-T1028 | In distribution | |
| SH-T0818 | In distribution | |
| SH-R1311 | In distribution | |
| SH-2004 | In distribution | |
| SH-M011 | In distribution | |
| SH-T5123 | In distribution | |
| SH-0813-S | In distribution | |
| SH-R1313 | In distribution | |
| SH-T0826 | In distribution | |
| SH-T1018 | In distribution | |
| SH-T0828 | In distribution | |
| SH-1024-SP | In distribution | |
| SH-T1540L | In distribution | |
| SH-1028-S | In distribution | |
| SH-T1540R | In distribution | |
| SH-R1312 | In distribution | |
| SH-1100 | In distribution | |
| SH-T3920 | In distribution | |
| SH-1741L | In distribution | |
| SH-M012 | In distribution | |
| SH-T1713 | In distribution | |
| SH-1022-SP | In distribution | |
| SH-0822-SP | In distribution | |
| SH-T1740L | In distribution | |
| SH-1020-S | In distribution | |
| SH-1020-SP | In distribution | |
| SH-1741R | In distribution | |
| SH-T3916 | In distribution | |
| SH-R1310 | In distribution | |
| SH-0828-S | In distribution | |
| SH-0818-S | In distribution | |
| SH-1026-SP | In distribution | |
| SH-1213-S | In distribution | |
| SH-T0713 | Withdrawn | |
| SH-T0813 | Withdrawn | |
| SH-2005 | Withdrawn | |
| SH-T1313 | Withdrawn | |
| SH-T0913 | Withdrawn | |
| SH-T1413 | Withdrawn | |
| SH-T1513 | Withdrawn | |
| SH-1400 | Withdrawn | |
| SH-1500 | Withdrawn | |
| SH-T1013 | Withdrawn | |
| SH-2000 | Withdrawn | |
| SH-1117 | Withdrawn | |
| SH-T1213 | Withdrawn | |
| SH-T1113 | Withdrawn | |
| SH-2001 | Withdrawn | |
| SH-1600 | Withdrawn | |
| SH-2006 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
| Prima | Limacorporate | 67 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Acumed LLC | 510(k) number | 2008-05-13 | Not classified | Labeling mix-ups | The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated. | 20 units | 2010-05-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.