Identity
- Trade Name
- MyKnee LBS FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-RM-#5+ FDA UDI
- Model / Reference
- 6.3625M FDA UDI
- Description
- MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-RM-#5+ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030893308 FDA UDI
- 510(k) Number
- K093806 FDA UDI
- FDA Product Code
- JWH 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
MyKnee LBS by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
- AGILITY — DEPUY ORTHOPAEDICS, INC. · Class I
- IO-FLEX — SPINAL ELEMENTS, INC. · Class II
- BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION — TORNIER, INC. · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medacta International
Sources (1)
- FDA UDI 9d9db65c-5f15-441e-b4a2-b60835bf4762 34 fields · synced Jun 6, 2026