FDA UDI
In Commercial Distribution
🇺🇸 United States
Optimotion Blue CR HCCR Total Knee System
DI: B6961014F17010
·
Model: 1014-F-1701
·
OPTIMOTION IMPLANTS LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Optimotion Blue CR HCCR Total Knee System
- Primary DI
- B6961014F17010
- Version / Model
- 1014-F-1701
- Company Name
- OPTIMOTION IMPLANTS LLC
- Labeler DUNS
- 056559377
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-27
- Public Version
- 1
- Public Version Date
- 2020-08-04
- Public Version Status
- New
- Public Device Record Key
- d677a646-6824-4c5a-a022-f6d1ddb070a8
Device Description
CR Femoral Component, Porous CoCr, Size 7, Left
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 |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 888.3560 | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | 888.3565 | 2 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33664 | Cruciate-retaining total knee prosthesis | A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative (e.g., arthritic) joint [total knee arthroplasty (TKA)]; it is designed to be implanted with retention of the posterior cruciate ligament. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE). The device may be implanted with or without bone cement and is typically used in cases where bone stock is good and supporting ligaments provide adequate stability. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B6961014F17010 | HIBCC |
Customer Contacts
- Phone
- 877-678-6686
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191084 | 000 |