FDA UDI
In Commercial Distribution
🇺🇸 United States
OsteoBridge™ IKA Knee Arthrodesis 10° Spacer
DI: 04048266078735
·
Model: 40 50
·
Merete GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OsteoBridge™ IKA Knee Arthrodesis 10° Spacer
- Primary DI
- 04048266078735
- Version / Model
- 40 50
- Catalog Number
- GA04041
- Company Name
- Merete GmbH
- Labeler DUNS
- 313267265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-15
- Public Version
- 7
- Public Version Date
- 2026-03-18
- Public Version Status
- Update
- Public Device Record Key
- a85c2880-7f13-43e9-a21f-1f143404abf0
Device Description
TiAl6V4 ELI sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67728 | Non-articulating total knee prosthesis spacer | A rigid, hollow cylindrical device that is a component of a non-articulating total knee prosthesis intended to be implanted between a femur and tibial stem (not included) to replace the knee joint, typically following failure of a primary knee prosthesis (revision). It is intended to be used in a single- or dual-spacer configuration which surrounds the adjacent ends of the stems, and is stabilized using screws. It is made of metal and may be straight or angled. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048266078735 | GS1 |
Customer Contacts
- Phone
- +1(630)613-7182
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101939 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 50 | Millimeter | |
| Outer Diameter | 40 | Millimeter |