Identity
- Trade Name
- Optimotion Blue CR HCCR Total Knee System FDA UDI
- Generic Name
- Joint prosthesis implantation kit, reusable FDA UDI
- Device Name
- Tibial Tray Template Sz 4 FDA UDI
- Model / Reference
- 1014-2-3004 FDA UDI
- Description
- Tibial Tray Template Sz 4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B6961014230040 FDA UDI
- 510(k) Number
- K191084 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDIOIY FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Joint prosthesis implantation kit, reusable
Optimotion Blue CR HCCR Total Knee System by Optimotion Implants, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Joint prosthesis implantation kit, reusable.
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- IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
- Evolution — MicroPort Orthopedics Inc. · Class II
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- ADVANCE® — MicroPort Orthopedics Inc. · Class I
- PROPHECY — MicroPort Orthopedics Inc. · Class II
Cleared under the same submission
K191084 also covers:
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Optimotion Implants, Llc
Sources (1)
- FDA UDI 82fee145-f80d-4c80-8e49-9332b87f84b0 35 fields · synced May 31, 2026