Latitude™ – Elbow
Ulnar Bushing
1manufacturer
38catalogue numbers in this listing
1510(k) clearance
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 | Tornier Inc., United States |
|---|---|
| FDA product code | JDC |
| Device type | Prosthesis, Elbow, Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3150 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K070787 |
| Record published | 2015-10-16 |
| Record revised | 2025-12-16 (version 6) |
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, manufacturing date, serial number |
| Sizes | Outer diameter 5 to 6.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DKY181 | Size SMALL | In distribution |
| DKY203 | Size MEDIUM | In distribution |
| DKY124 | Size MEDIUM | In distribution |
| DKY125 | Size LARGE | In distribution |
| DKY224 | Size MEDIUM | In distribution |
| DKY211 | Size SMALL | In distribution |
| DKY214 | Size MEDIUM | In distribution |
| DKY205 | Size LARGE | In distribution |
| DKY071 | Size SMALL | In distribution |
| DKY057 | Size MEDIUM | In distribution |
| DKY121 | Size MEDIUM | In distribution |
| DKY227 | Size LARGE + | In distribution |
| DKY059 | Size LARGE + | In distribution |
| DKY122 | Size LARGE | In distribution |
| DKY213 | Size MEDIUM | In distribution |
| DKY069 | Size LARGE | In distribution |
| DKY208 | Size LARGE + | In distribution |
| DKY120 | Size SMALL | In distribution |
| DKY062 | Outer Diameter 5 mm | In distribution |
| DKY207 | Size LARGE + | In distribution |
| DKY083 | Size LARGE | In distribution |
| DKY186 | Size LARGE | In distribution |
| DKY217 | Size LARGE + | In distribution |
| DKY222 | Size SMALL | In distribution |
| DKY085 | Size SMALL | In distribution |
| DKY206 | Size LARGE | In distribution |
| DKY081 | Size SMALL | In distribution |
| DKY184 | Size MEDIUM | In distribution |
| DKY185 | Size LARGE | In distribution |
| DKY123 | Size SMALL | In distribution |
| DKY075 | Size SMALL | In distribution |
| DKY204 | Size MEDIUM | In distribution |
| DKY061 | Outer Diameter 6.5 mm | In distribution |
| DKY192 | Size MEDIUM | In distribution |
| DKY182 | Size SMALL | In distribution |
| DKY202 | Size SMALL | In distribution |
| DKY201 | Size SMALL | In distribution |
| DKY073 | Size LARGE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nexel® | Zimmer, Inc. | 78 |
| DJO Surgical | Encore Medical, L.P. | 74 |
| Tema Elbow | Limacorporate | 72 |
| Discovery Elbow System | Biomet Orthopedics | 72 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 58 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K000003 | 2000-10-02 |
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.