FDA UDI
In Commercial Distribution
🇺🇸 United States
Orthopedic Salvage System (OSS)
DI: 00880304475755
·
Model: 161078
·
Biomet Orthopedics, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orthopedic Salvage System (OSS)
- Primary DI
- 00880304475755
- Version / Model
- 161078
- Catalog Number
- 161078
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 4
- Public Version Date
- 2020-05-05
- Public Version Status
- Update
- Public Device Record Key
- f849c3d8-abad-43cd-9d3a-f5c34dab8ecd
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
- 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 |
|---|---|---|---|---|
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | Orthopedic | 888.3350 | 2 |
| KRO | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | Orthopedic | 888.3510 | 2 |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58084 | Diaphysis prosthesis | An artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), 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 | 00880304475755 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1.5 CM |