Inhance
INHANCE SHOULDER SYSTEM CONVERTIBLE GLENOID X-LARGE X-LINKED VITAMIN E PE CAUTION:USE WITH MODULAR OR R/SPEED UNITI PLATFORM BASEPLATE Ø31.5mm
2manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | PAO |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K212737 |
| Record published | 2022-05-16 |
| Record revised | 2025-02-06 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5503-10-015 | In distribution | |
| 5200-00-040 | In distribution | |
| 5200-03-044 | In distribution | |
| 5120-00-110 | In distribution | |
| 5500-00-360 | In distribution | |
| 5100-26-500 | In distribution | |
| 5100-31-500 | In distribution | |
| 5505-40-004 | In distribution | |
| 5200-01-028 | In distribution | |
| 5200-02-032 | In distribution | |
| 5500-40-004 | In distribution | |
| 5500-36-004 | In distribution | |
| 550032040 | In distribution | |
| 5155-00-240 | In distribution | |
| 5500-36-100 | In distribution | |
| 5503-00-020 | In distribution | |
| 5200-01-032 | In distribution | |
| 5200-00-032 | In distribution | |
| 5507-06-100 | In distribution | |
| 5500-11-290 | In distribution | |
| 5500-11-240 | In distribution | |
| 5200-03-028 | In distribution | |
| 550032110 | In distribution | |
| 5505-32-008 | In distribution | |
| 5507-08-100 | In distribution | |
| 5503-00-030 | In distribution | |
| 6005-30-306 | In distribution | |
| 5505-36-104 | In distribution | |
| 5155-00-315 | In distribution | |
| 5100-21-522 | In distribution | |
| 5500-01-290 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 85 |
| Perform™ Humeral System | Tornier Inc. | 76 |
| Comprehensive® Reverse Shoulder | Biomet Orthopedics | 68 |
| Link Embrace Shoulder System | Waldemar Link GmbH & Co. KG | 64 |
| Anatomical Shoulder™ Domelock® | Zimmer, Inc. | 43 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 38 |
| Link Embrace Shoulder System Line Extension | Waldemar Link GmbH & Co. KG | 32 |
| Tornier Perform Humeral System | Tornier Inc. | 17 |
| Comprehensive Instrumentation | Biomet Orthopedics | 16 |
| Embrace Shoulder System | Waldemar Link GmbH & Co. KG | 13 |
| Maestro™ Total Wrist | Biomet Orthopedics | 13 |
| Comprehensive® | Zimmer, Inc. | 11 |
Showing 12 of 29. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
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.