Latitude™ - Elbow
- Primary DI
- 00846832010899
- Brand
- Latitude™ - Elbow
- Company
- TORNIER, INC.
- Model
- DKY062
- Published
- 2015-10-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| JDC | PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JDC | Prosthesis, Elbow, Constrained, Cemented | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00846832010899 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00846832010899 | 00846832010899 | 846832010899 | 0846832010899 |
GMDN Terms
| Term | Definition |
|---|
| Hinged total elbow prosthesis | A sterile implantable artificial substitute for an elbow joint designed to replace the articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes humeral and ulnar components, typically with parts made of metal and polyethylene (PE), that form a hinge at articulation. The device may include fixation devices (e.g., screws) for implantation and may be implanted with or without bone cement. |
Device Sizes
| Type | Value | Unit |
|---|
| Outer Diameter | 5 | Millimeter |
Regulatory Flags
- DUNS number
- 968990812
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 07613327668896 | Modular Elbow | Howmedica Osteonics Corp. | JDC | 2025-02-24 |
| 00889024649637 | Nexel® | Zimmer, Inc. | JDC | 2024-08-16 |
| 07613327627404 | SOLAR | Howmedica Osteonics Corp. | JDC | 2023-06-23 |
| 07613327627411 | SOLAR | Howmedica Osteonics Corp. | JDC | 2023-06-23 |
| 07613327627428 | SOLAR | Howmedica Osteonics Corp. | JDC | 2023-06-23 |
| 07613327627435 | SOLAR | Howmedica Osteonics Corp. | JDC | 2023-06-23 |
| 07613327627244 | SOLAR | Howmedica Osteonics Corp. | JDC | 2023-06-05 |
| 07613327627251 | SOLAR | Howmedica Osteonics Corp. | JDC | 2023-06-05 |
| 20801902194644 | ARROW | TELEFLEX INCORPORATED | JDC | 2022-11-08 |
| 00887868504051 | Comprehensive® SRS Instrument | Biomet Orthopedics, LLC | JDC | 2022-04-23 |
| 00887868504075 | Comprehensive® SRS Instrument | Biomet Orthopedics, LLC | JDC | 2022-04-23 |
| 00887868504099 | Comprehensive® SRS Instrument | Biomet Orthopedics, LLC | JDC | 2022-04-23 |
| 00887868504174 | Comprehensive® SRS Instrument | Biomet Orthopedics, LLC | JDC | 2022-04-23 |
| 00887868504181 | Comprehensive® SRS Instrument | Biomet Orthopedics, LLC | JDC | 2022-04-23 |
| 00887868504198 | Comprehensive® SRS Instrument | Biomet Orthopedics, LLC | JDC | 2022-04-23 |
| 00887868504228 | Comprehensive® SRS Instrument | Biomet Orthopedics, LLC | JDC | 2022-04-23 |
| 00846832012466 | Latitude™ - Elbow | TORNIER, INC. | JDC | 2022-03-31 |
| 37613327590051 | Axel Pin Assembly Standard Elbow | Howmedica Osteonics Corp. | JDC | 2022-03-23 |
| 37613327590075 | Bearing and Axle Bushing Assembly - Standard Elbow | Howmedica Osteonics Corp. | JDC | 2022-03-23 |
| 00889024639751 | NA | Zimmer, Inc. | JDC | 2022-02-25 |
| 00889024639768 | NA | Zimmer, Inc. | JDC | 2022-02-25 |
| 00889024639775 | NA | Zimmer, Inc. | JDC | 2022-02-25 |
| 00889024639782 | NA | Zimmer, Inc. | JDC | 2022-02-25 |
| 00889024639799 | NA | Zimmer, Inc. | JDC | 2022-02-25 |
| 00889024639805 | NA | Zimmer, Inc. | JDC | 2022-02-25 |
| 00889024466296 | Nexel® | Zimmer, Inc. | JDC | 2022-02-25 |
| 00887868543708 | Comprehensive® SRS | Biomet Orthopedics, LLC | JDC | 2021-11-21 |
| 00887868503375 | Comprehensive® SRS Instrument | Biomet Orthopedics, LLC | JDC | 2021-11-05 |
| 00887868503412 | Comprehensive® SRS Instrument | Biomet Orthopedics, LLC | JDC | 2021-11-05 |
| 00887868503436 | Comprehensive® SRS Instrument | Biomet Orthopedics, LLC | JDC | 2021-11-05 |
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