Aequalis™ Adjustable Reversed
25 catalogue numbers from 6130990, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
25catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-22 |
| Record revised | 2025-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | expiry date, serial number |
| Sizes | Length 15 to 110 mm; outer diameter 9 to 17 mm |
| Distribution end date | 2023-09-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6130990 | Outer Diameter 9 mm | In distribution |
| 6501700 | Length 100 mm | In distribution |
| 6501150 | Length 50 mm | In distribution |
| 6501120 | Length 20 mm | In distribution |
| 6500915 | Outer Diameter 9 mm | In distribution |
| 6501720 | Outer Diameter 17 mm | In distribution |
| 6101590 | Outer Diameter 15 mm | In distribution |
| 6501715 | Outer Diameter 17 mm | In distribution |
| 6131390 | Length 90 mm | In distribution |
| 6100990 | Outer Diameter 9 mm | In distribution |
| 6500925 | Length 25 mm | In distribution |
| 6121590 | Length 90 mm | In distribution |
| 6101710 | Length 110 mm | In distribution |
| 6501320 | Length 20 mm | In distribution |
| 6130910 | Length 110 mm | In distribution |
| 6101390 | Length 90 mm | In distribution |
| 6500920 | Length 20 mm | In distribution |
| 6401080 | Length 80 mm | Withdrawn |
| 6603617 | Outer Diameter 17 mm | Withdrawn |
| 6603611 | Outer Diameter 11 mm | Withdrawn |
| 6401020 | Length 20 mm | Withdrawn |
| 6401035 | Length 35 mm | Withdrawn |
| 6401085 | Length 85 mm | Withdrawn |
| 6401045 | Length 45 mm | Withdrawn |
| 6401070 | Length 70 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251686 | 2025-10-30 |
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.