Reunion
Cannulated TSA Half-Moon Reamer Size 56
8manufacturers in China registered for this device type
45catalogue numbers in this listing
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2022-11-15 |
| Record revised | 2025-04-14 (version 5) |
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, expiry date, manufacturing date |
| Sizes | Length 4 to 12 mm |
| Distribution end date | 2022-11-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5571-S-3612-E | Diameter: 36.0 Millimeter | In distribution |
| 5901-6094 | In distribution | |
| 5568-0012L | Distal Diameter: 12.0 Millimeter | In distribution |
| 5571-S-3608-E | Diameter: 36.0 Millimeter | In distribution |
| 5901-6075 | In distribution | |
| 5901-6074 | In distribution | |
| 5571-S-4004-E | Diameter: 40.0 Millimeter | In distribution |
| 5901-6070 | In distribution | |
| 5571-S-3604-E | Diameter: 36.0 Millimeter | In distribution |
| 5571-C-3204-E | Diameter: 32.0 Millimeter | In distribution |
| 5901-6092 | In distribution | |
| 5571-C-3610-E | Thickness: 10.0 Millimeter | In distribution |
| 5542-P-0044-E | In distribution | |
| 5571-S-4006-E | Diameter: 40.0 Millimeter | In distribution |
| 5901-6085 | In distribution | |
| 5542-K-0044-E | In distribution | |
| 5571-S-3208-E | Diameter: 32.0 Millimeter | In distribution |
| 5568-0006L | Distal Diameter: 6.0 Millimeter | In distribution |
| 5571-C-3206-E | Diameter: 32.0 Millimeter | In distribution |
| 5568-0008L | Distal Diameter: 8.0 Millimeter | In distribution |
| 5901-6095 | In distribution | |
| 5571-C-3604-E | Diameter: 36.0 Millimeter | In distribution |
| 5542-P-0056-E | In distribution | |
| 5571-S-4012-E | Diameter: 40.0 Millimeter | In distribution |
| 5571-C-3606-E | Thickness: 6.0 Millimeter | In distribution |
| 5571-C-3608-E | Thickness: 8.0 Millimeter | In distribution |
| 5542-P-0048-E | In distribution | |
| 5542-K-0044-A | Withdrawn | |
| 5571-S-4006-A | Diameter: 40.0 Millimeter | Withdrawn |
| 5571-S-4010-A | Diameter: 40.0 Millimeter | Withdrawn |
| 5571-C-3610-A | Length 10.0 mm | Withdrawn |
| 5542-P-0048-A | Withdrawn | |
| 5542-K-0056-A | Withdrawn | |
| 5571-C-3210-A | Length 10.0 mm | Withdrawn |
| 5571-S-3212-A | Length 12.0 mm | Withdrawn |
| 5571-C-4006-A | Length 6.0 mm | Withdrawn |
| 5571-S-4004-A | Diameter: 40.0 Millimeter | Withdrawn |
| 5571-C-3606-A | Diameter: 36.0 Millimeter | Withdrawn |
| 5571-C-3208-A | Diameter: 32.0 Millimeter | Withdrawn |
| 5571-S-3610-A | Thickness: 10.0 Millimeter | Withdrawn |
| 5571-C-4010-A | Length 10.0 mm | Withdrawn |
| 5542-P-0056-A | Withdrawn | |
| 5542-P-0044-A | Withdrawn | |
| 5571-C-3204-A | Length 4.0 mm | Withdrawn |
| 5571-C-3612-A | Length 12.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| 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 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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.