Alteon
- Primary DI
- 10885862653802
- Brand
- Alteon
- Company
- Exactech, Inc.
- Model
- 190-00-12
- Catalog number
- 190-00-12
- Device description
- Femoral Stem, Press-Fit, Standard Offset, Cementless, HA Coated, Collarless, Traditional Length, Size 12
- Published
- 2026-05-26
- Public version status
- New
- 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 |
|---|
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K243839 | 000 | Alteon® HA Femoral Stems | Exactech, Inc. | 2025-03-10 | MEH |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10885862653802 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10885862653802 | 10885862653802 |
GMDN Terms
| Term | Definition |
|---|
| Coated femoral stem prosthesis, modular | A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
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
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 10885862653697 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653703 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653710 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653727 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653734 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653741 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653758 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653765 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653772 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653789 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653796 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653819 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653826 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653833 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653840 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653857 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653864 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653871 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653888 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653895 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653901 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653918 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653925 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653932 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653949 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653956 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653963 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653970 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653987 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |
| 10885862653994 | Alteon | Exactech, Inc. | MEH | 2026-05-26 |