FDA UDI
In Commercial Distribution
🇺🇸 United States
Alteon
DI: 10885862520197
·
Model: 01-010-24-5295
·
Exactech, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alteon
- Primary DI
- 10885862520197
- Version / Model
- 01-010-24-5295
- Catalog Number
- 01-010-24-5295
- Company Name
- Exactech, Inc.
- Labeler DUNS
- 157565946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-04
- Public Version
- 1
- Public Version Date
- 2019-01-04
- Public Version Status
- New
- Public Device Record Key
- e2cf95cc-b6b6-4ee2-966a-fcab648bfade
Device Description
Alteon Monobloc Revision Stem
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33178 | Revision uncoated hip femur prosthesis | A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885862520197 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181532 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 295 | Millimeter | |
| Device Size Text, specify | Extended Offset | ||
| Outer Diameter | 24 | Millimeter |