Identity
- Trade Name
- My Knee Femoral Cutting Blocks FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- MRI Left Medial #2 FDA UDI
- Model / Reference
- 4.2012 FDA UDI
- Description
- MRI Left Medial #2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030851476 FDA UDI
- 510(k) Number
- K093806 FDA UDI
- FDA Product Code
- OOG FDA UDIJWH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
A comprehensive surgical instrument for orthopaedic prosthesis implantation, designed to aid in navigation and placement of the prosthesis or other instruments.
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
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- IO-FLEX — SPINAL ELEMENTS, INC. · Class II
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- MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left — Orthosoft Inc · Class II
- MyKnee PPS — Medacta International · Class II
Cleared under the same submission
K093806 also covers:
- My Knee — Medacta International
- My Knee Bone Models — Medacta International
- My Knee Femoral Cutting Blocks — Medacta International
- My Knee Femoral Cutting Blocks MIS — Medacta International
- My Knee Femoral Cutting Blocks MIS — Medacta International
- My Knee Femoral Cutting Blocks MIS — Medacta International
- My Knee Femoral Cutting Blocks MIS — Medacta International
- My Knee Tibial Cutting Blocks — Medacta International
- My Knee Tibial Cutting Blocks — Medacta International
- My Knee Tibial Cutting Blocks — Medacta International
- My Knee Tibial Cutting Blocks MIS — Medacta International
- My Knee Tibial Cutting Blocks MIS — Medacta International
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
- Medacta International
Sources (1)
- FDA UDI 66167a37-1073-40ed-ac02-685cd70082af 34 fields · synced Oct 6, 2026