FDA UDI
In Commercial Distribution
🇺🇸 United States
OsteoSinter® EVANS wedge 22W x 22L x 12H mm
DI: 08437019951542
·
Model: P00208B1
·
AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OsteoSinter® EVANS wedge 22W x 22L x 12H mm
- Primary DI
- 08437019951542
- Version / Model
- P00208B1
- Company Name
- AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
- Labeler DUNS
- 468566411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-14
- Public Version
- 1
- Public Version Date
- 2025-03-24
- Public Version Status
- New
- Public Device Record Key
- 51d81e9e-7d06-43fd-855e-901ffdecd974
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PLF | Bone Wedge | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61617 | Metallic osteotomy fusion cage, non-customized | A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437019951542 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240461 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged and consult instructions for use