AuRa
- Primary DI
- 10885862014863
- Brand
- AuRa
- Company
- Exactech, Inc.
- Model
- 106-44-24
- Catalog number
- 106-44-24
- Published
- 2015-10-30
- Public version status
- Update
- Distribution status
- Not 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 |
|---|
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | Orthopedic | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K962002 | 000 | AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM | Exactech, Inc. | 1996-08-08 | JDG |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10885862014863 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Revision uncoated femoral stem prosthesis | A sterile implantable device designed to replace the proximal femoral neck during replacement of a total hip prosthesis typically due to wear. The device is composed of two or more separate segments designed to be joined (modular), is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included; implantation is intended to be performed with bone cement and may involve use of a femoral extension. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Length | 180 | Millimeter |
Regulatory Flags
- DUNS number
- 157565946
- 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
- false
- Sterilization required before use
- false
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| 00885556918067 | Polar | Smith & Nephew, Inc. | JDG | 2024-04-10 |
| 00885556917558 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-07 |
| 00885556917473 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556917480 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556917497 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556917503 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556917510 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556917527 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556917534 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556917541 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556917565 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556917572 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556917589 | Anthology | Smith & Nephew, Inc. | JDG | 2024-03-06 |
| 00885556915615 | R3 | Smith & Nephew, Inc. | JDG | 2024-01-16 |
| 00885556915622 | Trigen | Smith & Nephew, Inc. | JDG | 2024-01-16 |
| 00885556915639 | Trigen | Smith & Nephew, Inc. | JDG | 2024-01-16 |
| 00885556915127 | Polar | Smith & Nephew, Inc. | JDG | 2023-11-21 |
| 00885556914083 | Anthology | Smith & Nephew, Inc. | JDG | 2023-11-13 |
| 00885556913970 | Polar | Smith & Nephew, Inc. | JDG | 2023-10-22 |
| 00885556913987 | Polar | Smith & Nephew, Inc. | JDG | 2023-10-22 |
| 00885556913345 | Polar | Smith & Nephew, Inc. | JDG | 2023-10-08 |
| 00885556913383 | Polar | Smith & Nephew, Inc. | JDG | 2023-10-08 |
| 00885556913390 | Polar | Smith & Nephew, Inc. | JDG | 2023-10-08 |
| 00885556913406 | ANTHOLOGY | Smith & Nephew, Inc. | JDG | 2023-10-08 |
| 00885556911518 | POLAR | Smith & Nephew, Inc. | JDG | 2023-09-20 |
| 00885556911068 | Polar | Smith & Nephew, Inc. | JDG | 2023-09-15 |