Shoulder Innovations InSet 95 Humeral Stem
Shoulder Innovations - InSet 95 Humeral Stem - Instrument Lever Lock Broach Handle Replaceable Compression Sleeve
5manufacturers in China registered for this device type
40catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
Record
| Listed by | Shoulder Innovations, Inc, United States |
|---|---|
| FDA product code | MBF |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3670 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K102670 |
| Record published | 2023-11-02 |
| Record revised | 2023-12-07 (version 2) |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12mm Stem Broach | In distribution | |
| Generic Jacobs Hall T Handle | In distribution | |
| 15mm Stem Broach | In distribution | |
| 12mm Reamer Sounder | In distribution | |
| 12x95mm | In distribution | |
| 13x95mm | In distribution | |
| Low Profile Lever Lock Broach Handle | In distribution | |
| 14x95mm | In distribution | |
| 8x95mm | In distribution | |
| Lever Lock Broach Handle | In distribution | |
| Impaction Stand | In distribution | |
| InSet 95 Instrument Case Insert Tray | In distribution | |
| Broach Handle | In distribution | |
| 16mm Reamer Sounder | In distribution | |
| 10mm Stem Broach | In distribution | |
| InSet 95 Instrument Case | In distribution | |
| 14mm Reamer Sounder | In distribution | |
| 6mm Reamer Sounder | In distribution | |
| 5mm Stem Broach | In distribution | |
| 6x95mm | In distribution | |
| Inserter | In distribution | |
| 11mm Stem Broach | In distribution | |
| 7mm Stem Broach | In distribution | |
| 9x95mm | In distribution | |
| 9mm Stem Broach | In distribution | |
| 10mm Reamer Sounder | In distribution | |
| 13mm Stem Broach | In distribution | |
| 5x95mm | In distribution | |
| 8mm Stem Broach | In distribution | |
| 14mm Stem Broach | In distribution | |
| Compression Sleeve | In distribution | |
| Generic Jacobs Hall Silicone T Handle | In distribution | |
| 6mm Stem Broach | In distribution | |
| 4mm Stem Broach | In distribution | |
| 4x95mm | In distribution | |
| 10x95mm | In distribution | |
| 8mm Reamer Sounder | In distribution | |
| 7x95mm | In distribution | |
| 15x95mm | In distribution | |
| 11x95mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 181 |
| Shoulder Innovations Humeral Short Stem System | Shoulder Innovations, Inc | 87 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 70 |
| BIO-Modular Shoulder System | Biomet Orthopedics | 41 |
| Comprehensive® SRS Instrument | Biomet Orthopedics | 36 |
| Identity™ | Zimmer, Inc. | 29 |
| Comprehensive® SRS | Biomet Orthopedics | 25 |
| Inhance | Depuy (Ireland) | 25 |
| SMR Shoulder | Limacorporate | 20 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Synthes (U.S.A.) LP | 19 |
| BI-Angular System | Biomet Orthopedics | 16 |
| Global Unite | Depuy (Ireland) | 16 |
Showing 12 of 71. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173824 | 2018-10-23 |
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.