Tema Elbow
Control Gauge for Implant Positioning – RIGHT
1manufacturer
72catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Limacorporate, Italy |
|---|---|
| FDA product code | JDC |
| Device type | Prosthesis, Elbow, Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3150 |
| Record published | 2019-05-24 |
| Record revised | 2026-02-09 (version 4) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1550.15.011 | small right | In distribution |
| 1575.14.030 | U6 | In distribution |
| 9015.04.005 | #H5 | In distribution |
| 9015.04.181 | #H8 – RIGHT | In distribution |
| 9015.50.111 | Small – RIGHT | In distribution |
| 9015.60.011 | Small – RIGHT | In distribution |
| 1504.14.071 | H7 right | In distribution |
| 9015.75.008 | #U4.5 – LEFT | In distribution |
| 9015.04.171 | #H7 – RIGHT | In distribution |
| 9015.90.140 | In distribution | |
| 9015.90.002 | RIGHT | In distribution |
| 9015.75.150 | #U7 | In distribution |
| 9015.04.110 | #H11/12 – LEFT | In distribution |
| 9015.52.900 | LEFT | In distribution |
| 9015.02.050 | Dia. 5 mm | In distribution |
| 9015.04.191 | #H9 – RIGHT | In distribution |
| 1504.14.080 | H8 left | In distribution |
| 1560.50.011 | small right | In distribution |
| 9015.75.110 | #U5 | In distribution |
| 9015.04.011 | #H11 | In distribution |
| 1560.50.020 | large left | In distribution |
| 1504.14.091 | H9 right | In distribution |
| 9015.75.007 | Dia. 2,5 mm | In distribution |
| 9015.60.141 | In distribution | |
| 9015.52.166 | RIGHT | In distribution |
| 9015.04.161 | #H6 – RIGHT | In distribution |
| 1575.14.010 | U5 | In distribution |
| 9015.75.041 | #U6.5 – RIGHT | In distribution |
| 9015.75.020 | #U5.5 – LEFT | In distribution |
| 9015.50.300 | LEFT | In distribution |
| 1552.14.021 | large right | In distribution |
| 9015.50.302 | In distribution | |
| 9015.04.101 | #H10 – RIGHT | In distribution |
| 1504.14.060 | H6 left | In distribution |
| 9015.52.010 | In distribution | |
| 9015.04.009 | #H9 | In distribution |
| 9015.75.060 | #U7.5 – LEFT | In distribution |
| 9015.50.175 | In distribution | |
| 9015.75.003 | LEFT | In distribution |
| 9015.04.201 | #H10 – RIGHT | In distribution |
| 9015.75.071 | #U8 – RIGHT | In distribution |
| 9015.75.005 | LEFT | In distribution |
| 9015.52.201 | In distribution | |
| 9015.04.050 | #H5 – LEFT | In distribution |
| 1550.15.900 | In distribution | |
| 9015.90.020 | Large | In distribution |
| 9015.75.050 | #U7 – LEFT | In distribution |
| 1504.14.100 | H10 left | In distribution |
| 9015.04.081 | #H8 – RIGHT | In distribution |
| 9015.75.144 | In distribution | |
| 9015.04.090 | #H9 – LEFT | In distribution |
| 9015.60.900 | In distribution | |
| 9015.52.001 | LEFT | In distribution |
| 9015.75.130 | #U6 | In distribution |
| 9015.60.020 | Large – LEFT | In distribution |
| 9015.04.070 | #H7 – LEFT | In distribution |
| 9015.52.031 | RIGHT | In distribution |
| 9015.50.141 | In distribution | |
| 9015.50.140 | In distribution | |
| 9015.04.251 | RIGHT | In distribution |
| 9015.75.002 | RIGHT | In distribution |
| 1550.15.020 | large left | In distribution |
| 9015.04.007 | #H7 | In distribution |
| 9015.50.201 | In distribution | |
| 1552.14.010 | small left | In distribution |
| 9015.75.031 | #U6 – RIGHT | In distribution |
| 9015.50.900 | In distribution | |
| 9015.50.165 | LEFT | In distribution |
| 9015.50.010 | Small | In distribution |
| 9015.50.121 | Large – RIGHT | In distribution |
| 9015.75.011 | #U5 – RIGHT | In distribution |
| 9015.04.061 | #H6 – RIGHT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nexel® | Zimmer, Inc. | 78 |
| DJO Surgical | Encore Medical, L.P. | 74 |
| Discovery Elbow System | Biomet Orthopedics | 72 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 58 |
| Latitude™ – Elbow | Tornier Inc. | 38 |
| Prosthesis, Elbow, Constrained, Cemented | Zimmer, Inc. | 37 |
| Latitude™ EV | Tornier Inc. | 36 |
| Comprehensive® SRS | Biomet Orthopedics | 31 |
| Comprehensive® SRS Instrument | Biomet Orthopedics | 30 |
| Solar | Howmedica Osteonics Corp | 27 |
| Zimmer® Nexel® Total Elbow | Zimmer, Inc. | 23 |
| Arrow | Teleflex Medical LLC | 13 |
Showing 12 of 28. All products under Prosthesis, Elbow, Constrained, 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.