FDA UDI
In Commercial Distribution
🇺🇸 United States
OsteoBridge™ IKA Knee Arthrodesis Nail
DI: 04048266130945
·
Model: with Collar 14 200
·
Merete GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OsteoBridge™ IKA Knee Arthrodesis Nail
- Primary DI
- 04048266130945
- Version / Model
- with Collar 14 200
- Catalog Number
- GA11420
- 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
- 2023-05-12
- Public Version Status
- Update
- Public Device Record Key
- 91803d29-7b0d-4e9e-aa5b-f44afd0ac28e
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
- No
- Has Donation ID
- No
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 |
|---|---|---|---|---|
| 58085 | Knee arthrodesis prosthesis | A fused (non-articulating) replacement for the knee joint intended to be implanted after failed primary knee arthroplasty and which functions as a bridge between the resected metaphyses of the femur and tibia. It is a modular device that typically includes resection elements (spacers), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048266130945 | GS1 |
Customer Contacts
- Phone
- +1(630)869-1092
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120978 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 200 | Millimeter | |
| Outer Diameter | 14 | Millimeter |