FDA UDI
In Commercial Distribution
🇺🇸 United States
Biocore9 Femoral Resurfacing Component
DI: 00810068850413
·
Model: Femoral Resurfacing Component - 44 mm
·
Biocore9, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Biocore9 Femoral Resurfacing Component
- Primary DI
- 00810068850413
- Version / Model
- Femoral Resurfacing Component - 44 mm
- Catalog Number
- 01-03-0044
- Company Name
- Biocore9, LLC
- Labeler DUNS
- 093081548
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-27
- Public Version
- 1
- Public Version Date
- 2021-10-05
- Public Version Status
- New
- Public Device Record Key
- 9dad2720-397e-45b8-88ab-4253fc88c3e6
Device Description
Biocore9 Femoral Resurfacing Head Component 44 mm
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 |
|---|---|---|---|---|
| KXA | Prosthesis, Hip, Femoral, Resurfacing | Orthopedic | 888.3400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64683 | Resurfacing metallic femoral head prosthesis | An implantable, metallic, partial substitute for a disease-damaged hip joint intended to replace the articulating surface of the femoral head while preserving the natural femoral head and neck. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810068850413 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201219 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 44 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius