Latitude™ EV
Humeral Stem - Coated
1manufacturer
36catalogue 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 |
| Record published | 2015-10-16 |
| Record revised | 2025-12-16 (version 6) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 25 to 200 mm; outer diameter 4.5 to 24 mm |
| Distribution end date | 2018-11-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0030030 | Size SMALL | In distribution |
| 0030041 | Length 150 mm | In distribution |
| 0830817 | Outer Diameter 6 mm | In distribution |
| 0830824 | Outer Diameter 22 mm | In distribution |
| 0030523 | Length 200 mm | In distribution |
| 0030010 | Length 41 mm | In distribution |
| 9039000 | Length 25 mm | In distribution |
| 0030211 | Length 52 mm | In distribution |
| 0830825 | Outer Diameter 24 mm | In distribution |
| 0030121 | Length 75 mm | In distribution |
| 0030711 | Length 77 mm | In distribution |
| 0030412 | Size MEDIUM | In distribution |
| 0030721 | Size LARGE | In distribution |
| 0030403 | Length 77 mm | In distribution |
| 0030220 | Size LARGE | In distribution |
| 0030021 | Size SMALL | In distribution |
| 0830821 | Length 35 mm | In distribution |
| 0030140 | Length 150 mm | In distribution |
| 0030131 | Length 125 mm | In distribution |
| 0030111 | Length 47 mm | In distribution |
| 9039004 | Length 55 mm | In distribution |
| 9039001 | Length 25 mm | In distribution |
| 0030700 | Length 72 mm | In distribution |
| 0030120 | Size MEDIUM | In distribution |
| 0030413 | Size MEDIUM | In distribution |
| 0030710 | Length 77 mm | In distribution |
| 0030312 | Size SMALL | In distribution |
| 0030210 | Length 52 mm | In distribution |
| 0830816 | Outer Diameter 4.5 mm | In distribution |
| 0030512 | Length 150 mm | In distribution |
| 0030241 | Length 150 mm | In distribution |
| 9039003 | Outer Diameter 8 mm | In distribution |
| 0030040 | Length 150 mm | In distribution |
| 0030231 | Length 125 mm | In distribution |
| 9039002 | Outer Diameter 6 mm | In distribution |
| DKY066 | Withdrawn |
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 |
| Latitude™ – Elbow | Tornier Inc. | 38 |
| Prosthesis, Elbow, Constrained, Cemented | Zimmer, Inc. | 37 |
| 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.