FDA UDI
In Commercial Distribution
🇺🇸 United States
TARA FEMORAL COMPONENT 41
DI: M209100860
·
Model: 10086
·
BIOPRO, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TARA FEMORAL COMPONENT 41
- Primary DI
- M209100860
- Version / Model
- 10086
- Company Name
- BIOPRO, INC.
- Labeler DUNS
- 618749857
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-16
- Public Version
- 4
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 223fc01b-8681-46d7-b8f2-4cf9d0484f1b
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
- Yes
- 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 |
|---|---|---|---|---|
| 33717 | Resurfacing metallic hip prosthesis | An implantable partial substitute for a disease-damaged hip joint intended to replace the articulating surfaces of the hip while preserving the natural femoral head and neck. It consists of a metallic femoral cap component, that is placed over (resurfaces) a surgically-prepared femoral head, and a metallic acetabular component; that is, both components are supplied together. 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 | M209100860 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043542 | 000 |